Mechanisms for controlling rotation of outer cannula for use in endoscopic tool

ABSTRACT

A surgical instrument includes a cutting assembly, an outer tubing, and a flexible torque component. The cutting assembly extends from a first proximal end to a first distal end. The cutting assembly includes an outer cannula defining a cutting window and an inner cannula disposed within the outer cannula. The outer tubing extends from a proximal tubing end to a distal tubing end. The distal tubing end is coupled to the outer cannula. The outer tubing is configured to receive a torque at the proximal tubing end and transmit the torque to the outer cannula to rotate the outer cannula. The outer tubing includes a plurality of first wires and a plurality of second wires each including more than eight wires and less than twenty four wires. The flexible torque component is coupled to a third proximal end of the inner cannula to rotate the inner cannula.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.15/885,219, entitled “MECHANISMS FOR CONTROLLING ROTATION OF OUTERCANNULA FOR USE IN ENDOSCOPIC TOOL”, filed on Jan. 31, 2018, whichclaims the benefit of and priority to U.S. Provisional Application No.62/453,466, filed Feb. 1, 2017, entitled “MECHANISMS FOR CONTROLLINGROTATION OF OUTER CANNULA FOR USE IN ENDOSCOPIC TOOL,” the entiredisclosure of each of which is incorporated herein for any and allpurposes.

BACKGROUND

Metaplasia, such as intestinal metaplasia and polyps, inside a subject,if left untreated may result in unfavorable outcomes, such as cancer. Assuch, physicians recommend the removal of such growths to prevent theonset of cancer and other undesirable diseases.

SUMMARY

An improved endoscopic instrument is provided that can precisely removesessile polyps and efficiently obtain samples of multiple polyps from apatient. In particular, the improved endoscopic instrument is capable ofdebriding one or more polyps and retrieving the debrided polyps withouthaving to alternate between using a separate cutting tool and a separatesample retrieving tool. The sampling can be integrated with colonoscopyinspection. In some implementations, the endoscopic instrument can cutand remove tissue from within a patient. In some such implementations,the endoscopic instrument can cut and remove tissue substantiallysimultaneously from within a patient accessed through a flexibleendoscope.

In one aspect, a surgical instrument includes a cutting assembly, aflexible outer tubing, and a flexible torque component. The cuttingassembly is configured to resect material at a site within a subject.The cutting assembly extends from a first proximal end to a first distalend. The cutting assembly includes an outer cannula and an inner cannuladisposed within the outer cannula. The outer cannula defines a cuttingwindow. The flexible outer tubing extends from a proximal tubing end toa distal tubing end. The distal tubing end is coupled to the outercannula. The flexible outer tubing is configured to receive a torque atthe proximal tubing end and transmit the torque to the outer cannula torotate the outer cannula. The flexible outer tubing includes a pluralityof first wires and a plurality of second wires each including more thaneight wires and less than twenty four wires. The flexible torquecomponent is coupled to a third proximal end of the inner cannula andconfigured to rotate the inner cannula relative to the outer cannula.

In another aspect, a surgical instrument includes a cutting assembly, aflexible outer tubing, and a flexible torque component. The cuttingassembly extends from a first proximal end to a first distal end. Thecutting assembly includes an outer cannula and an inner cannula disposedwithin the outer cannula. The outer cannula defines a cutting window.The flexible outer tubing extends from a proximal tubing end to a distaltubing end. The distal tubing end is coupled to the outer cannula. Theflexible outer tubing is configured to receive a torque at the proximaltubing end and transmit the torque to the outer cannula to rotate theouter cannula. The flexible outer tubing includes a plurality of firstwires and a plurality of second wires each including twelve wires. Theflexible torque component is coupled to a third proximal end of theinner cannula and configured to rotate the inner cannula relative to theouter cannula.

In another aspect, a surgical instrument includes an end effector and aflexible outer tubing. The end effector is configured to be rotated bythe flexible outer tubing to perform a surgical procedure at a site onor within a subject. The flexible outer tubing extends from a proximaltubing end to a distal tubing end. The distal tubing end is coupled tothe end effector so that the flexible outer tubing can receive a torqueat the proximal tubing end and transmit the torque to the end effector.The flexible outer tubing includes a plurality of first wires and aplurality of second wires oriented at an angle relative to the pluralityof first wires. The plurality of first wires and plurality of secondwires each include more than eight wires and less than twenty fourwires.

In another aspect, an endoscopic instrument insertable within a singleinstrument channel of an endoscope includes a power-driven instrumenthead configured to resect material at a site within a subject havingbeen reached by a flexible endoscope with working channel. Thepower-driven instrument head has a first distal end and a first proximalend. The first distal end of the power-driven instrument head defines amaterial entry port through which the resected material can enter theflexible endoscopic instrument. A body is coupled to the first proximalend of the power-driven instrument head and configured to drive thepower-driven instrument head. The body includes a flexible portion thathas a second distal end and a second proximal end. The second proximalend of the flexible portion defines a material exit port. An aspirationchannel extends from the material entry port of the power-driveninstrument head to the material exit port of the flexible portion. Thesecond proximal end of the flexible portion is configured to couple to avacuum source such that the resected material entering the aspirationchannel via the material entry port is removed from the aspirationchannel at the material exit port while the endoscopic instrument isdisposed within an instrument channel of a flexible endoscope.

In some implementations, the body further includes a powered actuator.The powered actuator is coupled to the first proximal end of thepower-driven instrument head and configured to drive the power-driveninstrument head. In some implementations, the powered actuator is one ofa hydraulically powered actuator, a pneumatically powered actuator or anelectrically powered actuator. In some implementations, the poweredactuator includes at least one of an electric motor, a tesla rotor, anda vane rotor. In some implementations, the endoscopic instrumentincludes an energy storage component configured to power the poweredactuator. In some implementations, the aspiration channel is defined bythe power-driven instrument head, the powered actuator and the flexibleportion.

In some implementations, the powered actuator is one of a hydraulicallypowered actuator or a pneumatically powered actuator. In some suchimplementations, the flexible portion includes a fluid inlet tubularmember configured to supply irrigation to actuate the power actuator anda fluid outlet tubular member configured to remove the fluid beingsupplied to actuate the actuator. In some implementations, the flexibleportion includes an aspiration tubular member that defines a proximalportion of the aspiration channel.

In some implementations, the powered actuator includes a hollow portion,the hollow portion fluidly coupling the material entry port of thepower-driven instrument head and the material exit port of the flexibleportion.

In some implementations, the instrument includes an engagement assemblyconfigured to contact the walls of the instrument channel of theendoscope when actuated. In some implementations, the engagementassembly includes a compliant ring structure configured to be deformed.

In some implementations, the power-driven instrument head includes anouter structure and a cutting shaft disposed within the outer structure,the cutting shaft coupled to the powered actuator and configured torotate relative to the outer structure when the powered actuator isactuated. In some implementations, the cutting shaft includes a hollowportion and the material entry port.

In some implementations, the flexible portion includes a hollow flexibletorque cable. The flexible torque cable has a distal region configuredto couple to the first proximal end of the power-driven instrument headand has a proximal region configured to couple to a powered actuator. Insome implementations, the flexible torque cable defines a portion of theaspiration channel. The distal region of the flexible torque cable isfluidly coupled to the material entry port of the power-driveninstrument head and the proximal region of the flexible torque cableincludes the material exit port.

In some implementations, the instrument has an outer diameter that isless than about 5 mm. In some implementations, the flexible portion isat least 40 times as long as the power-driven instrument head. In someimplementations, the outer diameter of the powered actuator is less thanabout 4 mm.

According to another aspect, an endoscopic instrument includes apower-driven instrument head configured to resect material at a sitewithin a subject. The power-driven instrument head includes a cuttingtip and a material entry port configured to allow material to enter adistal end of the endoscopic instrument. A body is coupled to thepower-driven instrument head. The body includes an elongated hollowflexible tubular member that includes a material exit port configured toallow material to exit a proximal end of the endoscopic instrument. Anaspiration channel extends from the material entry port of thepower-driven instrument head to a material exit port of the elongatedhollow flexible tubular member. The second proximal end of the flexibleportion is configured to fluidly couple to a vacuum source such that theresected material that enters the aspiration channel via the materialentry port of the power-driven instrument head is removed from theendoscopic instrument via the material exit port. The endoscopicinstrument is configured to travel through a tortuous instrument channelof an endoscope. In some implementations, the instrument has an outerdiameter that is less than about 5 mm and wherein the flexible tubularmember is at least 72 inches long.

In some implementations, the body further comprises a powered actuator,the powered actuator coupled to the first proximal end of thepower-driven instrument head and configured to drive the power-driveninstrument head. In some implementations, the powered actuator is anelectrically powered actuator and further comprising an electricallyconducting wire configured to couple to a power source. In someimplementations, the aspiration channel is defined by the power-driveninstrument head, the powered actuator and the flexible portion. In someimplementations, the flexible tubular member defines a proximal portionof the aspiration channel.

In some implementations, the powered actuator is one of a hydraulicallypowered actuator or a pneumatically powered actuator, and furtherincludes a fluid inlet tubular member configured to supply fluid toactuate the power actuator and a fluid outlet tubular member configuredto remove the fluid being supplied to actuate the actuator.

In some implementations, the instrument includes an engagement assemblyconfigured to contact the walls of the instrument channel of theendoscope when actuated. In some implementations, the engagementassembly includes a vacuum actuated structure configured to move into anengaged position in which the vacuum actuated structure is not incontact with the instrument channel when the vacuum is actuated andconfigured to move into a retracted position in which the vacuumactuated structure is not in contact with the instrument channel whenthe vacuum is not actuated.

In some implementations, the power-driven instrument head includes anouter structure and a cutting shaft disposed within the outer structure,the cutting shaft coupled to the powered actuator and configured torotate relative to the outer structure when the powered actuator isactuated.

In some implementations, the flexible tubular member includes a hollowflexible torque cable. The flexible torque cable has a distal regionconfigured to couple to the first proximal end of the power-driveninstrument head and has a proximal region configured to couple to apowered actuator located external to the endoscopic instrument. In someimplementations, the flexible torque cable further defines a portion ofthe aspiration channel, wherein the distal region of the flexible torquecable is fluidly coupled to the material entry port of the power-driveninstrument head and the proximal region of the flexible torque cableincludes the material exit port. In some implementations, the instrumentincludes a sheath surrounding the flexible torque cable.

According to another aspect, a flexible endoscopic biopsy retrieval tooladapted for use with an endoscope includes a housing, a debridingcomponent coupled to the housing, and a sample retrieval conduitdisposed within the housing for retrieving debrided material that isdebrided by the debriding component. In various embodiments, an improvedflexible endoscope may be configured with an integrated endoscopicbiopsy retrieval tool that includes a debriding component and a sampleretrieval conduit for retrieving debrided material that is debrided bythe debriding component.

According to another aspect, a method of retrieving polyps from apatient's body includes disposing an endoscopic instrument within aninstrument channel of an endoscope, inserting the endoscope in apatient's body, actuating a debriding component of the endoscopicinstrument to cut a polyp within the patient's body, and actuating asample retrieval component of the endoscopic instrument to remove thecut polyp from within the patient's body.

According to yet another aspect, an endoscope includes a first end and asecond end separated by a flexible housing. An instrument channelextends from the first end to the second end and an endoscopicinstrument is coupled to the instrument channel at the first end of theendoscope. The endoscopic instrument includes a debriding component anda sample retrieval conduit partially disposed within the instrumentchannel.

According to yet another aspect, an endoscopic instrument insertablewithin a single instrument channel of an endoscope includes a cuttingassembly that is configured to resect material at a site within asubject. The cutting assembly includes an outer cannula and an innercannula disposed within the outer cannula. The outer cannula defines anopening through which material to be resected enters the cuttingassembly. The endoscopic instrument also includes a flexible outertubing coupled to the outer cannula and configured to cause the outercannula to rotate relative to the inner cannula. The flexible outertubing can have an outer diameter that is smaller than the instrumentchannel in which the endoscopic instrument is insertable. The endoscopicinstrument also includes a flexible torque coil having a portiondisposed within the flexible outer tubing. The flexible torque coilhaving a distal end coupled to the inner cannula. The flexible torquecoil is configured to cause the inner cannula to rotate relative to theouter cannula. The endoscopic instrument also includes a proximalconnector coupled to a proximal end of the flexible torque coil andconfigured to engage with a drive assembly that is configured to causethe proximal connector, the flexible torque coil and the inner cannulato rotate upon actuation. The endoscopic instrument also includes anaspiration channel having an aspiration port configured to engage with avacuum source. The aspiration channel is partially defined by an innerwall of the flexible torque coil and an inner wall of the inner cannulaand extends from an opening defined in the inner cannula to theaspiration port. The endoscopic instrument also includes an irrigationchannel having a first portion defined between an outer wall of theflexible torque coil and an inner wall of the flexible outer tubing andconfigured to carry irrigation fluid to the aspiration channel.

In some implementations, the proximal connector is hollow and an innerwall of the proximal connector defines a portion of the aspirationchannel. In some implementations, the proximal connector is a rigidcylindrical structure and is configured to be positioned within a drivereceptacle of the drive assembly. The proximal connector can include acoupler configured to engage with the drive assembly and a tensioningspring configured to bias the inner cannula towards a distal end of theouter cannula. In some implementations, the tensioning spring is sizedand biased such that the tensioning spring causes a cutting portion ofthe inner cannula to be positioned adjacent to the opening of the outercannula. In some implementations, the proximal connector is rotationallyand fluidly coupled to the flexible torque coil.

In some implementations, the endoscopic instrument also includes alavage connector including an irrigation entry port and a tubular membercoupled to the lavage connector and the flexible outer tubing. An innerwall of the tubular member and the outer wall of the flexible torquecoil can define a second portion of the irrigation channel that isfluidly coupled to the first portion of the irrigation channel. In someimplementations, the endoscopic instrument also includes a rotationalcoupler coupling the flexible outer tubing to the tubular member andconfigured to cause the flexible outer tubing to rotate relative to thetubular member and cause the opening defined in the outer cannula torotate relative to the inner cannula. In some implementations, thelavage connector defines an inner bore within which the flexible torquecoil is disposed.

In some implementations, the endoscopic instrument also includes alining within which the flexible torque coil is disposed, the outer wallof the lining configured to define a portion of the irrigation channel.In some implementations, the inner cannula is configured to rotateaxially relative to the outer cannula and the aspiration channel isconfigured to provide a suction force at the opening of the innercannula.

In some implementations, the flexible torque coil includes a pluralityof threads. Each of the plurality of threads can be wound in a directionopposite to a direction in which one or more adjacent threads of theplurality of threads is wound. In some implementations, the flexibletorque coil includes a plurality of layers. Each of the plurality oflayers can be wound in a direction opposite to a direction in which oneor more adjacent layers of the plurality of layers is wound. In someimplementations, each layer can include one or more threads.

In some implementations, the flexible outer tubing has a length thatexceeds the length of the endoscope in which the endoscopic instrumentis insertable. In some implementations, the flexible outer tubing has alength that is at least 100 times larger than an outer diameter of theflexible outer tubing. In some implementations, the flexible portion isat least 40 times as long as the cutting assembly.

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intendedthat this Summary be used to limit the scope of the claimed subjectmatter. Furthermore, the claimed subject matter is not limited toimplementations that offer any or all advantages or solve any or allstate of the art problems.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure is illustratively shown and described inreference to the accompanying drawing in which:

FIG. 1A illustrates various types of polyps that can form within a body.

FIG. 1B illustrates a perspective partial view of an endoscope accordingto embodiments of the present disclosure.

FIG. 1C illustrates a perspective view of an endoscopic instrumentaccording to embodiments of the present disclosure.

FIGS. 2A and 2B illustrate side perspective views of an endoscopicinstrument coupled with the endoscope shown in FIG. 1 according toembodiments of the present disclosure.

FIGS. 3A and 3B illustrate side perspective views of an exampleendoscopic instrument coupled with the endoscope shown in FIG. 1according to embodiments of the present disclosure.

FIG. 4A illustrates an exploded view of the endoscopic instrument thatcan be coupled with the endoscope according to embodiments of thepresent disclosure.

FIG. 4B illustrates a perspective view diagram of the endoscopicinstrument coupled to the endoscope illustrating the various conduitsassociated with the endoscopic instrument.

FIG. 5 illustrates a side perspective view of another example endoscopicinstrument coupled with the endoscope shown in FIG. 1 according toembodiments of the present disclosure.

FIG. 6 illustrates an enlarged view of an example endoscopic instrumentaccording to embodiments of the present disclosure.

FIG. 7 illustrates a perspective view of an outer blade of a cuttingtool of the endoscopic instrument shown in FIG. 6 according toembodiments of the present disclosure.

FIG. 8 illustrates a perspective view of an inner blade of the cuttingtool of the endoscopic instrument shown in FIG. 6 according toembodiments of the present disclosure.

FIG. 9 illustrates a perspective view of a rotor of the endoscopicinstrument shown in FIG. 6 according to embodiments of the presentdisclosure.

FIG. 10 illustrates a perspective view of a casing of the endoscopicinstrument shown in FIG. 6 according to embodiments of the presentdisclosure.

FIG. 11 illustrates a perspective view of a cap of the endoscopicinstrument shown in FIG. 6 according to embodiments of the presentdisclosure.

FIG. 12 illustrates a perspective view of a coupling member of theendoscopic instrument shown in FIG. 6 according to embodiments of thepresent disclosure.

FIG. 13 illustrates a perspective view diagram of the endoscopicinstrument coupled to the endoscope illustrating the various conduitsassociated with the endoscopic instrument.

FIG. 14 illustrates another perspective view diagram of the endoscopicinstrument coupled to the endoscope illustrating the various conduitsassociated with the endoscopic instrument.

FIG. 15 is a conceptual system architecture diagram illustrating variouscomponents for operating the endoscopic instrument according toembodiments of the present disclosure.

FIG. 16A illustrates an exploded view of an example endoscopicinstrument according to embodiments of the present disclosure.

FIG. 16B illustrates a cross-sectional view of the endoscopic instrumentshown in FIG. 16A according to embodiments of the present disclosure.

FIG. 16C illustrates a schematic view of an example engagement assemblyof an example endoscopic instrument according to embodiments of thepresent disclosure.

FIG. 16D shows a cut-open view of the engagement assembly shown in FIG.16C when the engagement assembly is disengaged according to embodimentsof the present disclosure.

FIG. 16E shows a cut-open view of the engagement assembly shown in FIG.16A when the engagement assembly is configured to engage with aninstrument channel of an endoscope according to embodiments of thepresent disclosure.

FIG. 17A illustrates an exploded view of an example endoscopicinstrument according to embodiments of the present disclosure.

FIG. 17B illustrates a cross-sectional view of the endoscopic instrumentshown in FIG. 17A according to embodiments of the present disclosure.

FIG. 18A illustrates an exploded view of an example endoscopicinstrument utilizing a tesla rotor according to embodiments of thepresent disclosure.

FIG. 18B illustrates a cross-sectional view of the endoscopic instrumentshown in FIG. 18A according to embodiments of the present disclosure.

FIG. 19A illustrates an example endoscopic instrument that is coupled toa powered actuation and vacuum system according to embodiments of thepresent disclosure.

FIG. 19B illustrates a cross-section view of the powered actuation andvacuum system shown in FIG. 19A according to embodiments of the presentdisclosure.

FIG. 19C illustrates an exploded view of an example head portion of theendoscopic instrument shown in FIG. 19A according to embodiments of thepresent disclosure.

FIG. 19D illustrates a cut-open view of a portion of the endoscopicinstrument having an engagement assembly according to embodiments of thepresent disclosure

FIG. 19E shows a cut-open view of the engagement assembly shown in FIG.19D in a disengaged position according to embodiments of the presentdisclosure.

FIG. 19F shows a cut-open view of the engagement assembly shown in FIG.19D in an engaged position according to embodiments of the presentdisclosure.

FIG. 20 is a conceptual system architecture diagram illustrating variouscomponents for operating the endoscopic instrument according toembodiments of the present disclosure.

FIGS. 21AA-21F illustrate aspects of an endoscopic assembly according toembodiments of the present disclosure.

FIGS. 22A-22H show various implementations of example flexible cablesaccording to embodiments of the present disclosure.

FIGS. 23AA-23BB show an example implementation of a cutting toolaccording to embodiments of the present disclosure.

FIGS. 24A-24C illustrate various aspects of the drive shaft of thecoupling component according to embodiments of the present disclosure.

FIG. 25 illustrates an example housing component according toembodiments of the present disclosure.

FIGS. 26A-26E show an example sleeve bearing according to embodiments ofthe present disclosure.

FIGS. 27A-27C show an example base plate that forms a portion of thecasing according to embodiments of the present disclosure.

FIGS. 28A-28D show an example side plate that forms a portion of thecasing according to embodiments of the present disclosure.

FIGS. 29AA-29EE show various aspects of ferrules according toembodiments of the present disclosure

FIGS. 30AA-30C illustrate aspects of an endoscopic assembly in which thetip is press-fit according to embodiments of the present disclosure.

FIGS. 31AA-31AB and 31B-31C illustrate aspects of an endoscopic assemblyin which the tip is press-fit according to embodiments of the presentdisclosure.

FIG. 32 shows a top view of an example flexible portion of an endoscopictool according to embodiments of the present disclosure.

FIG. 33 is a cross-sectional view of an example cutting assembly of anendoscopic tool using a torque rope according to embodiments of thepresent disclosure.

FIGS. 34A-34C are cross-sectional views of different configurations ofthe flexible portion region of one implementation of an endoscopic tooldescribed herein.

FIG. 35AA-35AC shows various views of portions of an endoscopic toolaccording to embodiments of the present disclosure.

FIG. 36 shows a cross-sectional view of the flexible portion region ofone implementation of an endoscopic tool according to embodiments of thepresent disclosure.

FIG. 37 shows a cross-section view of one implementation of theendoscopic tool according to embodiments of the present disclosure.

FIGS. 38A and 38B show various views of a distal portion of oneimplementation of an endoscopic tool according to embodiments of thepresent disclosure.

FIGS. 39A and 39B show cross-sectional views of the distal portion ofthe endoscopic tool shown in FIGS. 38A and 38B along the sections B-Band sections C-C according to embodiments of the present disclosure.

FIG. 40A shows a perspective view of an endoscopic tool and a portion ofa drive assembly configured to drive the endoscopic tool according toembodiments of the present disclosure.

FIG. 40B shows a perspective view of the endoscopic tool and the portionof the drive assembly configured to drive the endoscopic tool shown inFIG. 40A according to embodiments of the present disclosure.

FIG. 41 shows a top view of the endoscopic tool and a top exposed viewof the portion of the drive assembly shown in FIGS. 40A-40B according toembodiments of the present disclosure.

FIG. 42 shows a cross-sectional view of the endoscopic tool and theportion of the drive assembly across the section A-A shown in FIGS.40A-40B according to embodiments of the present disclosure.

FIG. 43 shows an enlarged view of the drive connector of the endoscopeand the portion of the drive assembly shown in FIGS. 40A-40B accordingto embodiments of the present disclosure.

FIG. 44 shows a perspective view of the endoscopic tool and a portion ofthe drive assembly shown in FIGS. 40A-40B according to embodiments ofthe present disclosure.

FIG. 45 shows a cross-sectional view of the endoscopic tool and theportion of the drive assembly across the section B-B according toembodiments of the present disclosure.

FIG. 46 shows an enlarged cross-sectional view of the rotational couplersection of the endoscopic tool according to embodiments of the presentdisclosure.

FIG. 47A and FIG. 47B show a top view and a cross-sectional view of therotational coupler of the endoscopic tool according to embodiments ofthe present disclosure.

FIG. 48 is a perspective view of a portion of the endoscopic toolinserted for operation within a drive assembly according to embodimentsof the present disclosure.

FIG. 49 illustrates another implementation of the endoscopic tool and adrive assembly configured to drive the endoscopic tool according toembodiments of the present disclosure.

FIG. 50A is a side view of the endoscopic tool and drive assembly shownin FIG. 49 according to embodiments of the present disclosure.

FIG. 50B is a cross-sectional view of the endoscopic tool and driveassembly shown in FIG. 49 taken along the section A-A according toembodiments of the present disclosure.

FIG. 51 is a schematic diagram of a surgical system including a surgicalinstrument having an improved flexible outer tubing according toembodiments of the present disclosure.

FIG. 52 is a cross-section view of the improved flexible outer tubing ofFIG. 51 according to embodiments of the present disclosure.

DETAILED DESCRIPTION

A. Improved Endoscopic Instrument Systems and Methods

Technologies provided herein are directed towards an improved flexibleendoscopic instrument that can precisely and efficiently obtain samplesof single and multiple polyps and neoplasms from a patient. Inparticular, the improved endoscopic instrument is capable of debridingsamples from one or more polyps and retrieving the debrided sampleswithout having to remove the endoscopic instrument from the treatmentsite within the patient's body.

FIG. 1A illustrates various types of lesions that can form within abody. Many polyps may be removed by snare polypectomy, though especiallylarge polyps and/or sessile or flat polyps must be removed piecemealwith biopsy forceps or en bloc using endoscopic mucosal resection (EMR).A recent study has concluded that depressed sessile polyps had thehighest rate for harboring a malignancy at 33%. The same study has alsofound that non-polypoid neoplastic lesions (sessile polyps) accountedfor 22% of the patients with polyps or 10% of all patients undergoingcolonoscopy. There are multiple roadblocks to resecting colon polyps,namely the difficulties in removing sessile polyps, the time involved inremoving multiple polyps and the lack of reimbursement differential forresecting more than one polyp. Since resecting less accessible sessilepolyps presents challenges and multiple polyps take more time perpatient, most polyps are removed piece meal with tissue left behind aspolyps increase in size, contributing to a sampling bias where thepathology of remaining tissue is unknown, leading to an increase in thefalse negative rate.

Colonoscopy is not a perfect screening tool. With current colonoscopypractices the endoscopist exposes the patient to sample bias throughpiecemeal EMR sessile/flat polyps. Sessile polyps are extremelydifficult or impossible to remove endoscopically with current techniquesand often incompletely resected. Current colonoscopy instruments forpolyp resection are limited by their inability to adequately removesessile polyps and inefficiency to completely remove multiple polyps.Sessile polyp fragments that are left behind after incomplete resectionwill grow into new polyps and carry risks for malignancy. Physicianstreating lesions in other parts of a subject's body face similar issues,for instance, Barrett's esophagus, and pulmonary tumors among others.

In the recent past, endoscopic mucosal resection (EMR) has been adoptedto remove sessile polyps. EMR involves the use of an injection toelevate surrounding mucosa followed by opening of a snare to cut thepolyp and lastly use of biopsy forceps or a retrieval device to removethe polyp. The introduction and removal of the injection needle andsnare through the length of the colonoscope, which is approximately 5.2feet, must be repeated for the forceps.

The present disclosure relates to an endoscopic tool that is capable ofdelivering an innovative alternative to existing polyp removal tools,including snares, hot biopsy and EMR, by introducing a flexible poweredinstrument that that works with the current generation colonoscopes andcan cut and remove any polyp. The endoscopic tool described herein canbe designed to enable physicians to better address sessile or largepolyps as well as remove multiple polyps in significantly less time.Through the adoption of the endoscopic tool described herein, physicianscan become more efficient at early diagnosis of colorectal cancer.

The present disclosure will be more completely understood through thefollowing description, which should be read in conjunction with thedrawings. In this description, like numbers refer to similar elementswithin various embodiments of the present disclosure. Within thisdescription, the claims will be explained with respect to embodiments.The skilled artisan will readily appreciate that the methods, apparatusand systems described herein are merely exemplary and that variationscan be made without departing from the spirit and scope of thedisclosure.

Referring back to the drawings, FIG. 1B illustrates a perspectivepartial view of an endoscope according to embodiments of the presentdisclosure. Although the present disclosure is directed towardsendoscopic instruments adapted for use with any type of endoscope, forsake of convenience, the teachings of the present disclosure aredirected towards endoscopic instruments used with a lower GI scope, suchas a colonoscope. It should, however, be appreciated that the scope ofthe present disclosure is not limited to endoscopic instruments for usewith GI scopes, but extends to any type of flexible endoscope, includingbut not limited to bronchoscopes, gastroscopes and laryngoscopes, orother medical devices that may be used to treat patients.

According to various embodiments, a typical lower GI scope 100 includesa substantially flexible member that extends from a first end or headportion 102 to a second end or handle portion. The head portion 102 maybe configured to swivel so as to orient a tip 104 of the head portion102 in any direction within a hemispherical space. The handle portionhas controls that allows the operator of the endoscope 100 to steer thecolonoscope towards an area of interest within the colon and turn thecorners between colon segments with two steering wheels.

A series of instruments reside on the face 106 of the scope's tip 104,including but not limited to, one or more water channels 108A-108N,generally referred to as water channels 108, for irrigating the areawith water, one or more light sources 110A-110N, generally referred toas light sources 110, a camera lens 112, and an instrument channel 120through which an endoscopic instrument can be passed through to conducta number of operations. The instrument channel 120 can vary in sizebased on the type of endoscope 100 being used. In various embodiments,the diameter of the instrument channel 120 can range from about 2 mm to6 mm, or more specifically, from about 3.2 mm to 4.3 mm. Some largerscopes may have two instrument channels 120 so that two tools can bepassed into the patient simultaneously. However, larger scopes may causediscomfort to the patient and may be too large to enter the patient'sbody through some of the smaller cavities.

FIG. 1C illustrates a perspective view of an endoscopic instrument 150according to embodiments of the present disclosure. The endoscopicinstrument 150 is configured to be fed through the instrument channel120 of the endoscope 100 depicted in FIG. 1B. The endoscopic instrument150 is configured to be inserted within an instrument channel of anendoscope, such as the instrument channel 120 of the endoscope 100depicted in FIG. 1B. In some implementations, the portion of theendoscopic instrument 150 that is configured to be inserted within theinstrument channel 120 may be sized to have an outer diameter that issmaller than the inner diameter of the instrument channel 120 of theendoscope. In some such implementations, the endoscopic instrument 150can be sized to have an outer diameter that is sufficiently small to beslidably inserted within the instrument channel while the endoscope iscoiled or bent. When the endoscope is coiled or bent, the instrumentchannel can form a tortuous path that includes one or more curves andbends. In one example implementations, an endoscope includes aninstrument channel that has an inner diameter of about 4.3 mm when theendoscope is straightened. However, when the endoscope is coiled orbent, portions of the endoscope near the bends can have clearances thatare smaller than the inner diameter of about 4.3 mm. In someimplementations, the endoscope can have clearances that may be about 3.8mm instead of the 4.3 mm achieved when the endoscope is straightened. Insome implementations, the endoscope can have clearances that may beabout 3.2 mm. As such, in some implementations, the endoscopicinstrument 150 may be sized such that it can be slidably inserted withinthe instrument channel of the endoscope with which it is to be used evenwhen the endoscope is coiled or bent.

In some implementations, the endoscopic instrument 150 includes apower-driven instrument head 160 configured to resect material at a sitewithin a subject. The power-driven instrument head 160 has a distal end162 and a proximal end 161. The distal end 162 of the power-driveninstrument head 160 defines a material entry port 170 through which theresected material can enter the endoscopic instrument 150. Thepower-driven instrument head 160 can include a cutting section at thedistal end 162 that is configured to cut tissue and other material. Asused herein, a port can include any opening, aperture, or gap throughwhich material can either enter or exit. In some implementations, thematerial entry port can be an opening through which resected materialcan enter the endoscopic instrument 150. In some implementations,material to be resected can be suctioned into the material entry portwhere the instrument head can then resect the material.

A body 152 includes a head portion 155 and a flexible portion 165. Adistal end 156 of the head portion 155 of the body 152 is coupled to theproximal end 161 of the power-driven instrument head 160. In someimplementations, the head portion 155 of the body 152 is configured todrive the power-driven instrument head 160. A proximal end 158 of thehead portion 155 can be coupled to a distal end 166 of the flexibleportion 165. A proximal end 176 of the flexible portion 165 defines amaterial exit port 175. The flexible portion 165 can include a hollowflexible tubular member.

The endoscopic instrument also includes an aspiration channel thatextends from the material entry port 170 of the power-driven instrumenthead 160 to the material exit port 175 of the flexible portion 165. Insome implementations, the aspiration channel is defined by thepower-driven instrument head 160, the head portion 155 of the body 152and the flexible portion 165 of the body. The proximal end 176 of theflexible portion 165 is configured to couple to a vacuum source suchthat the resected material entering the aspiration channel via thematerial entry port 170 is removed from the aspiration channel at thematerial exit port 175 while the endoscopic instrument 150 is disposedwithin an instrument channel of an endoscope.

The head portion 155 includes a housing that has an outer diameter thatis configured such that the endoscopic instrument 150 can be slidablyinserted into an instrument channel of an endoscope. In someimplementations, the head portion 155 can include a powered actuatorthat is configured to drive the power-driven instrument head 160. Insome implementations, the powered actuator is disposed within the headportion 155. In some implementations, the powered actuator is locatedexternal to the portion of the endoscopic instrument 150 that can beinserted into an instrument channel of an endoscope. In someimplementations, the powered actuator is capable of driving thepower-driven instrument head via a shaft that can translate motiongenerated by the power actuator to the power-driven instrument head. Insome implementations, the powered actuator is not a part of theendoscopic instrument 150, but instead, is coupled to the power-driveninstrument head 160. In some implementations, the shaft may be aflexible shaft. In some such implementations, the flexible shaft can bea flexible torque coil, additional details of which are provided belowwith respect to FIGS. 19A-19C.

The endoscopic instrument 150 can be sized to be insertable within aninstrument channel of an endoscope. In some implementations, theendoscopic instrument 150 may be sized such that the endoscopicinstrument can be inserted within the instrument channel of theendoscope while the endoscope is inserted within a subject. In some suchimplementations, the endoscope, for example, a colonoscope, may becurved or bent thereby requiring the endoscopic instrument 150 to besized such that it can be inserted into a curved or bent endoscope.

In some implementations, the head portion 155 and the power-driveninstrument head 160 of the endoscopic instrument 150 may besubstantially stiff or rigid, while the flexible portion 165 may berelatively flexible or compliant. The head portion 155 and thepower-driven instrument head 160 can be substantially rigid. As such, insome such implementations, the head portion 155 and the power-driveninstrument head 160 may be sized, at least in thickness and in length,such that endoscopic instrument 150 can maneuver through sharp bends andcurves during insertion of the endoscopic instrument 150 within theinstrument channel of the endoscope. In some implementations, the lengthof the power-driven instrument head 160 may be between about 0.2″-2″,about 0.2″ and 1″ or in some implementations, between 0.4″ and 0.8″. Insome implementations, the outer diameter of the power-driven instrumenthead 160 may be between about 0.4″-1.5″, 0.6″ and 1.2″ and 0.8″ and 1″.In some implementations, the length of the head portion 155 of the bodymay be between about 0.5″-3″, about 0.8″ and 2″ and 1″ and 1.5″.

The length of the flexible portion 165 may be substantially and/orrelatively longer than the length of the head portion and thepower-driven instrument head 160. In some implementations, the flexibleportion 165 can be sufficiently long such that the combined length ofthe endoscopic instrument exceeds the length of instrument channel of anendoscope in which the instrument can be inserted. As such, the lengthof the flexible portion 165 may have a length that exceeds about 36″,about 45″ or about 60″. For endoscopic instruments configured for usewith other types of endoscopes, the length of the flexible portion maybe shorter than 36″, but still sufficiently long to allow for the bodyof the endoscopic instrument to be approximately the same length orgreater than the length of the endoscope with which the instrument isbeing used.

The outer diameter of the flexible portion 165 can also be configuredsuch that the endoscopic instrument can be inserted into the instrumentchannel of the endoscope. In some implementations, the outer diameter ofthe flexible portion 165 can be sized smaller than a corresponding innerdiameter of the instrument channel of the endoscope. In some suchimplementations, the endoscopic instrument can be sized to have an outerdiameter that is sufficiently small to be slidably disposed within theendoscope while the endoscope is coiled or bent. For example, anendoscope can include an instrument channel that has an inner diameterof about 4.3 mm when the endoscope is straightened. However, when theendoscope is coiled or bent, portions of the endoscope near the bendscan have clearances that are smaller than the inner diameter of about4.3 mm. In some implementations, the endoscope can have clearances thatmay be as low as 3.2 mm. As such, in some implementations, theendoscopic instrument may be sized such that the endoscopic instrumentcan be slidably inserted within the instrument channel of the endoscopeeven when the endoscope is coiled or bent.

FIGS. 2A and 2B and 3A and 3B illustrate side perspective views of anendoscopic instrument coupled with the endoscope shown in FIG. 1Baccording to embodiments of the present disclosure. The endoscopicinstrument 220 is configured to be fed through the instrument channel120 of the endoscope 100. As shown in FIGS. 2A and 2B, the endoscopicinstrument 220 is capable of extending outside the tip 104 of theendoscope 100, while FIGS. 3A and 3B show that the endoscope tool 220can be retracted within the endoscope such that no part of theendoscopic instrument 220 is extending beyond the tip 104 of theendoscope 100. As will be described in further detail with respect toFIG. 4, the endoscopic instrument 220 is capable of cutting or debridinga polyp as well as obtaining the debrided polyp from the treatment sitewithout having to remove the endoscopic instrument 220 from theendoscope 100.

FIG. 4A illustrates an exploded view of the endoscopic instrument 220adapted for use with the endoscope 100 according to embodiments of thepresent disclosure. The endoscopic instrument 220 includes a debridingcomponent for debriding polyps grown in the patient's body, and a sampleretrieval component for retrieving the debrided polyps from the surgicalsite. The endoscopic instrument 220 includes a tubing 410 coupled to acap 420. In various embodiments, the cap 420 may be sealingly engagedwith the tubing 410. The cap can be aligned with a spindle 430 at afirst portion of the spindle 430. In various embodiments, the spindle430 may be substantially hollow. The spindle 430 can be coupled to arotor 440, which is configured to rotate the spindle 430. A secondportion of the spindle 430 includes an inner blade 450 that may beconfigured to interact with an outer blade 460. In some implementations,the outer blade 460 can be separated from the inner blade by a gap thatforms an irrigation channel (not shown). A casing 470 is configured toencompass the cap 420 and the rotor 440, as shown above with respect toFIGS. 2A and 3A. It should be appreciated that other components, such aswashers, bearings, seals, and the like, may be included in theendoscopic instrument 220.

FIG. 4B is a schematic diagram of an endoscopic instrument partiallyinserted within an instrument channel of an endoscope endoscopicinstrument. In various embodiments, the cap, connector, rotor and casingmay be made from injection molded plastic. The spindle and the cannulamay be made from surgical grade steel, and the tubing may be made fromsilicone. However, it should be appreciated that these materials aremerely examples of materials that can be used. Those skilled in the artwill appreciate that other materials may be used instead of the onesdescribed above.

The tubing 410 in FIG. 4A may be sized to pass through the instrumentchannel 120 of the endoscope 100 in FIGS. 4A and 4B. The tubing 410 mayinclude one or more pneumatic fluid entry conduits 412, one or morepneumatic fluid exit conduits 414, one or more irrigation conduits 416,and one or more suction conduits 418. The pneumatic fluid entry conduits412 arc configured to supply pressurized air to pneumatically drive therotor 440, while the pneumatic fluid exit conduits 414 remove the airsupplied by the pneumatic fluid entry conduits 412 to prevent a largeamount of air from entering the patient's body. The irrigation conduits416 supply an irrigation fluid, such as water, between the inner blade450 and the outer blade 460 to help lubricate the area between the innerblade 450 and the outer blade 460. In addition, the irrigation fluidthen flows from the outside of the inner blade 450 to the inside portionof the inner blade 450. It should be appreciated that the inside portionof the inner blade 450 may be aligned with the suction conduit 418 ofthe tubing 410 via the cap 420 such that any fluid that enters the innerblade 450 can pass through the inner blade 450 into the suction conduit418 of the tubing 410. The irrigation fluid that flows through theinside portion of the inner blade 450 and the suction conduit 418 helpslubricate the suction conduit 418, through which the debrided polyps andother waste from the patient's body are removed. As described above, thetubing 410 is coupled to the cap 420 at a first end, but is coupled toone or more components at a second end (not shown). For instance, at thesecond end, the pneumatic air entry conduits 412 may be coupled to acompressed air source, while the irrigation fluid conduit 416 may becoupled to a water supply source. In addition, the pneumatic fluid exitconduits 414 may be coupled to the compressed air source or simply leftexposed outside the patient's body for venting.

In various embodiments, the suction conduit 418 may be coupled to adisposable cartridge that is configured to catch the cut polyps andstore them for examination at a later time. In various embodiments, thedisposable cartridge may include multiple collection bins. The operatormay be capable of selecting the collection bin in which to collect asample of a particular cut polyp. Upon selecting the collection bin, thesuction conduit 418 supplies the collected material from within thepatient's body to the particular collection bin. As such, the operatormay be able to collect samples for each polyp in individual collectionbins. In this way, the cancerous nature of individual polyps can bedetermined.

The cap 420 may be sized to fit within the first end of the tubing 410.In various embodiments, the first end of the tubing 410 may include aconnector that is configured to couple with the cap 420. In variousembodiments, the cap 420 may be press fitted into the connector of thetubing 410. As such, the cap 420 may include corresponding conduits thatmatch the conduits of the tubing 410. Accordingly, compressed air fromthe compressed air source may be supplied through the pneumatic airentry conduits 412 of the tubing 410 and corresponding pneumatic airentry conduits of the cap 420 towards the rotor 440. The rotor 440 mayinclude one or more rotor blades 442 on which the compressed air isimpinged thereby causing the rotor 440 to rotate. The air impinging onthe rotor blades 442 may then exit through the corresponding pneumaticair exit conduits of the cap and the pneumatic air entry conduits 414 ofthe tubing 410. The speed at which the rotor 440 can rotate depends onthe amount of air and the pressure at which the air is supplied to therotor 440. In various embodiments, the speed at which the rotor 440rotates may be controlled by the operator of the endoscope 100. Althoughthe present disclosure discloses pneumatic means for operating therotor, some embodiments may include hydraulic means for operating therotor. In such embodiments, a fluid, such as water, may be supplied inlieu of compressed air, in the pneumatic air entry conduit 412.

As described above, the spindle 430 is coupled to the rotor 440, suchthat when the rotor 440 rotates, the spindle 430 also rotates. Invarious embodiments, the first end of the spindle 430 includes the innerblade 450, which correspondingly, also rotates along with the rotor 440.The inner blade 450 may be sized to fit within the diameter of the outerblade 460. In various embodiments, irrigation fluid supplied from anirrigation fluid source may be supplied through the irrigation fluidconduit 416 of the tubing 410 and the corresponding conduit of the cap420, along the space between the inner blade 450 and the outer blade460, and into the suction conduit 418 defined by the inner diameter ofthe inner blade 450. It should be appreciated that since the suctionconduit 418 is coupled to a vacuum source, fluids and other material maybe suctioned through the suction conduit. In this way, the irrigationfluid is able to lubricate at least a substantial length of the suctionconduit 418, from the tip 452 of the inner blade 450, through thespindle 430, cap 420, and tubing 410 into the disposable cartridgedescribed above.

The inner blade 450 may rotate relative to the outer blade 460 such thatthe interaction between the inner blade 450 and the outer blade 460causes polyps to he cut upon contact with the inner blade 450. Invarious embodiments, other mechanisms for cutting polyps may beutilized, which may or may not include the use of a rotor 440, innerblade 450 or outer blade 460.

The debriding component may generally be configured to debride a polyp.Debriding can, for example, include any action involving detaching thepolyp or a portion of the polyp from a surface of the patient's body.Accordingly, actions, including but not limited to, cutting, snaring,shredding, slicing, shattering, either entirely or partially, are alsoexamples of debriding. Accordingly, the debriding component may be acomponent that is capable of cutting, snaring, shredding, slicing,shattering, a polyp from a surface of the patient's body. As such, thedebriding component may be implemented as a forceps, scissor, knife,snare, shredder, or any other component that can debride a polyp. Insome embodiments, the debriding component may be manually actuated suchthat the debriding component may be operated through the translation ofmechanical forces exerted by an operator or automatically actuated,using a turbine, electrical motor, or any other force generatingcomponent to actuate the debriding component. For instance, thedebriding component may be actuated hydraulically, pneumatically, orelectrically. In various embodiments, a separate conduit passing throughthe tubing or a channel of the endoscope may be configured to carry anelectrical wire to provide power to the electrically powered actuator,such as an electrical motor.

According to various embodiments, the debriding component may include aturbine assembly, which is made up of the rotor 440, the rotor blades442, and the spindle 430. The operator may actuate the debridingcomponent of the endoscopic instrument by supplying compressed air tothe turbine assembly. When the operator is ready to begin debriding thepolyp, the operator actuates the turbine assembly causing the debridingcomponent to be actuated. In embodiments, such as the embodimentdisclosed in FIG. 4, actuating the debriding component may constitutecausing the inner blade 450 to rotate relative to the outer blade 460.Upon actuation, the operator may bring the endoscopic instrument 220towards the polyp to be debrided causing the inner blade 450 to debridethe polyp, causing portions of the debrided polyp to lie in the vicinityaround the area where the polyp had grown. The operator may thende-actuate the turbine assembly and actuate suction through the suctionconduit 418. The operator may then bring the inner blade close to thecut polyp causing the cut polyp to be retrieved through the suctionconduit 418. In various embodiments, the suction component of theendoscopic instrument may be actuated while the debriding component isactuated, thereby allowing any debrided material to be retrieved by thesuction component.

Although the above embodiment houses a debriding component that utilizesa turbine assembly, the scope of the present disclosure is not limitedto such embodiments. Rather, it should be appreciated by those skilledin the art that the debriding component may be manually operated or mayutilize any other means of debriding a polyp such that the debridedpolyps are capable of being retrieved from the surgical site via thesuction conduit described above. Accordingly, examples of debridingcomponents may include, but are not limited to, snips, blades, saws, orany other sharp tools that may or may not be driven by a turbineassembly. It should be appreciated that using a debriding component thatis able to cut a polyp into small enough pieces may be desirable suchthat the cut pieces may be retrieved via the suction conduit withouthaving to remove the endoscopic instrument from the endoscope.

The geometry and assembly of the turbine assembly for rotating at leastone of the cutting tool blades may be based on fluid dynamics.Bernoulli's equation can be used to explain the conversion between fluidpressure and the fluid velocity. According to this equation, the fluidvelocity is related to the initial fluid pressure by the equation:

$V = \sqrt{2*\frac{P}{D}}$where V is Velocity, P is Pressure, and D is Mass density.

In order for the fluid to reach the calculated velocity, the fluid canbe developed at the point of exit such that the channel through whichthe fluid is flowing meets an empirically determined L/D ratio of 2,where ‘D’ is the wetted diameter of the flow and the ‘L’ is the lengthof the channel.

To further understand the interaction of the rotor blades and the fluid,it is assumed that the rotor blade is made so that the air jet impingesthe rotor blade on a plane. The equation of linear momentum can beapplied to find the forces generated:

${\sum F} = {{\frac{d}{dt}\left( {\int{\int{\int{{Vp}*{{dVol}.}}}}} \right)} + {\sum\left( {\overset{.}{m}V} \right)_{out}} - {\sum\left( {\overset{.}{m}V} \right)_{in}}}$where: {dot over (m)} is the mass flow of the impinging air jet, and VisVolume.

Assuming that the control volume remains constant (volume betweenblades), the force created on the blade can be solved for:ΣF={dot over (m)}(V _(out) −V _(in))

The quantity V_(out) and V_(in) are the same in an impulse turbine, themomentum change being created by the changing direction of the fluidonly. The mass flow m is defined by the pump that is to be specified.The actual numerical value also needs to account for the velocity of therotor. So finally, the force generated by a single blade-air jetinteraction is:ΣF={dot over (m)}(V _(jet) −V _(rotor))−(V _(jet) −V _(rotor))cos θ)ΣF={dot over (m)}(V _(jet) −V _(rotor))(1−cos θ)where ‘θ’ is the difference of the angle between the incoming air jet tothat of the exiting air jet. Thought theoretically, the maximum amountof torque can be generated by a ‘θ’ value of 180°, but doing so willactually send the incoming jet onto the back of the following blade.Accordingly, the angle is best given a design value 15° to 20° below 180to allow a fluid a clean exit. Finally, the force can be defined into arotational torque:ΣT=({dot over (m)}/r)(V _(jet) −V _(rotor))(1−cos θ)

A second force that can be considered comes from redirecting the air jetfrom the nozzle into the turbine wheel. To power the turbine, the airjet can be turned 90° into the direction of the blades from thedirection of the air jet. The turning of the air jet will create a forceon the stationary housing that is a function of the jet velocity, whichin turn is proportional to the applied pressure:ΣF={dot over (m)}V _(jet)

This force can be reacted by the connection between the housing and theendoscope, a failure to do so can result in the ejection of the turbineassembly during operation.

Computational analyses based on Finite Element Methods (FEM) reveal thatthe areas where the greatest stresses are found are located near theroot of the blade where a sharp corner is located. The design of airinput channel can be simplified by the existing air nozzle channel inendoscope. The air nozzle in existing endoscopes directs pressurized airacross objective lens to remove moisture and also provides distension ofa cavity being examined or directs pressurized water across objectivelens to clear debris.

Referring now to FIG. 4B, a perspective view diagram of the endoscopicinstrument coupled to the endoscope illustrating the various conduitsassociated with the endoscopic instrument is shown. In particular, thepneumatic air entry conduit 412 is shown supplying pressurized air tothe rotor assembly, while the pneumatic air exit conduit 412 (not shownin this view) removes the air from the rotor assembly to outside theendoscope 100. The irrigation channel 416 is shown to carry irrigationfluid into the endoscopic instrument 220, where the irrigation fluidenters into the suction conduit 418, which carries material from withinthe patient's body to a collection component outside the endoscope. Asshown in FIG. 4B, the irrigation fluid may enter the suction conduit 418at an irrigation fluid entry opening 419. It should be appreciated thatthe placement of the irrigation fluid entry opening 419 may be placedanywhere along the suction conduit. Due to the suction force beingapplied to the suction conduit, irrigation fluid may be forced into thesuction conduit without the risk of the materials flowing in the suctionconduit from flowing outside the suction conduit through the irrigationfluid entry opening 419. Moreover, in some embodiments, the irrigationchannel may only supply irrigation fluid to the endoscopic instrumentwhile suction is being applied to the suction conduit.

FIG. 5 illustrates a side perspective view of another endoscopicinstrument coupled with the endoscope shown in FIG. 1 according toembodiments of the present disclosure. The add-on endoscopic instrument500 is sized to couple with the walls defining the instrument channel120 of the tip 104 of the endoscope 100. In various embodiments, theadd-on endoscopic instrument 500 may be removably attached to theinstrument channel 120 of the endoscope 100 at the tip 104 of theendoscope 104 by way of an interference fit or a press fit. In otherembodiments, the add-on endoscopic instrument 500 may be coupled to theendoscope 100 using other attachment means known to those skilled in theart.

Referring now to FIG. 6, an enlarged view of the add-on endoscopicinstrument 500 is shown. The add-on endoscopic instrument includes anouter blade or support member 510, an inner blade 520 disposed withinthe outer blade 510, a rotor 530 coupled to the inner blade 520 andencompassed by a casing 540. The casing is coupled to a cap 550, whichis further coupled to a connector 560. In some embodiments, theconnector 560 may be sized to engage with the inner diameter of theinstrument channel 120 of the endoscope 100. In some embodiments, anyother component of the endoscopic instrument may be configured to engagewith the endoscope 100 in such a manner as to secure the endoscopicinstrument to the instrument channel 120.

FIGS. 7-12 illustrate perspective views of the individual components ofthe add-on endoscopic instrument shown in FIG. 6 according toembodiments of the present disclosure. In contrast to the endoscopicinstrument 220 disclosed with respect to FIGS. 1-4, the add-onendoscopic instrument 500 may be adapted to fit within a first end ofinstrument channel 120 of the endoscope 100.

In various embodiments, a second end of the instrument channel 120 maybe coupled to a vacuum source, which causes material to be suctionedthrough the instrument channel 120. A suction conduit extends from thevacuum source through the instrument channel of the endoscope, andfurther through the connector 560, the cap 550, and the rotor 530, to afirst end of the inner blade 520, which has an opening defined by theinner diameter of the inner blade 520. It should be appreciated that theconnector 560, the cap 550, the casing 540, and the rotor 530 haverespective center bores 566, 556, 546 and 536 that are aligned such thatmaterials are allowed to flow from the opening of the inner blade 520 tothe vacuum source via the second end of the instrument channel 120.

In addition, the casing 540 of the add-on endoscopic instrument 500includes a pneumatic air entry port 542 and a pneumatic air exit port544 as shown in FIG. 10. The pneumatic air entry port 542 may be adaptedto receive compressed air from a compressed air source through apneumatic air entry conduit that passes along the length of theendoscope 100 to outside the patient's body, while the pneumatic airexit port 544 may be adapted to vent air that is impinged on the rotor530 through a pneumatic air exit conduit that passes along the length ofthe endoscope 100 to outside the patient's body. In this way, the rotormay be actuated by supplying compressed air from the compressed airsource, as described above with respect to FIGS. 1-4. It should beappreciated that although the rotor and associated components disclosedherein describe the use of pneumatic air, the rotor may he drivenhydraulically. In such embodiments, the pneumatic air conduits may beconfigured to carry a liquid, such as water, to and from the area aroundthe rotor.

Referring now also to FIG. 13, it should be appreciated that thepneumatic air entry and exit conduits may extend from the add-onendoscopic instrument to a pneumatic air source through the instrumentchannel 120 of the endoscope 100. In such embodiments, a tubing thatincludes separate conduits for the pneumatic air entry and exit conduitsand the suction conduit may extend from outside the endoscope to theadd-on endoscopic instrument within the endoscope. The tubing may becapable of being fed through the instrument channel of the endoscope andcoupled to the add-on endoscopic instrument 500. In such embodiments,the add-on endoscopic instrument 500 may be configured with anadditional component that has predefined channels that couple therespective channels of the tubing with the associated with the pneumaticair entry and exit openings of the add-on endoscopic instrument and thesuction conduit formed within the add-on endoscopic instrument. Inaddition, an irrigation fluid channel may also be defined within thetubing such that irrigation fluid may be supplied to the add-onendoscopic instrument 500, from where the irrigation fluid is divertedinto the suction conduit.

In various embodiments, the tip of the outer blade 510 may be sharp andmay cause discomfort to the patient while entering a cavity of thepatient's body. As such, a guard structure (not shown), such as a gelcap or other similar structure, may be attached to the outer blade priorto inserting the add-on endoscopic instrument into the patient's body toprevent injuries from the outer blade contacting a surface of thepatient's body. Once the endoscopic instrument is inserted in thepatient's body, the guard structure may be released from the outer blade510. In various embodiments, the guard structure may dissolve uponentering the patient's body.

Referring now to FIG. 14, an improved endoscope having a built in polypremoval assembly is shown according to embodiments of the presentdisclosure. The improved endoscope 1400 may be similar to conventionalendoscopes in many aspects, but may differ in that the improvedendoscope may include a built in polyp removal assembly 1440 within aninstrument channel of the endoscope 1400. The polyp removal assembly1440 may include a turbine assembly having a rotor 1442 with rotorblades sealed in a casing 1444 that has one or more inlet and outletports for allowing either pneumatic or hydraulic fluid to actuate therotor 1442. The inlet ports may be designed such that the fluid mayinteract with the rotor blades at a suitable angle to ensure that therotor can be driven at desired speeds.

In addition, the polyp removal assembly 1440 may be coupled to aconnector 1420, which is configured to couple the polyp removal assembly1440 to a tubing 1470. The tubing 1470 may include a pneumatic air entryconduit 1412, a pneumatic air exit conduit (not shown), an irrigationfluid conduit 1416 and a suction conduit 1418 that passes through thecenter of the turbine assembly. The tubing 1440 may be sized such thatthe tubing 1440 can be securely coupled to the connector 1420 such thatone or more of the conduits of the tubing 1440 are coupled tocorresponding conduits within the connector 1440. The connector 1420 maybe designed to include an irrigation fluid entry opening 419, whichallows irrigation fluid to pass into the suction conduit 1418 of thetubing 1440 when the tubing is coupled to the connector.

The turbine assembly of the endoscope 1400 may be configured to couplewith a removable debriding assembly 1460, which includes a spindle and acannula, in a manner that causes the debriding assembly to beoperational when the turbine assembly is operating.

In other embodiments of the present disclosure, an endoscope may bedesigned to facilitate debriding one or more polyps and removing thedebrided material associated with the polyps in a single operation. Invarious embodiments, the endoscope may include one or more separatechannels for removing debrided material, supplying irrigation fluid, andsupplying and removing at least one of pneumatic or hydraulic fluids. Inaddition, the endoscope may include a debriding component that may befixedly or removably coupled to one end of the endoscope. In variousembodiments, based on the operation of the debriding component, aseparate debriding component channel may also be designed for thedebriding component. In addition, the endoscope may include a light anda camera. In one embodiment, the endoscope may utilize existing channelsto supply pneumatic or hydraulic fluids to the actuator of theendoscopic instrument for actuating the debriding component. Forinstance, in the endoscope shown in FIG. 1, the water channels 108A-Nmay be modified to supply fluids to the actuator pneumatically orhydraulically. In such embodiments, the endoscopic instrument mayinclude a connector having a first end capable of being coupled to anopening associated with existing channels 108 of the endoscope, whileanother end of the connector is exposed to an opening at the actuator.

In various embodiments of the present disclosure, the endoscopicinstrument may further be configured to detect the presence of certainlayers of tissue. This may be useful for physicians to take extraprecautions to prevent bowel perforations while debriding polyps. Insome embodiments, the endoscopic instrument may be equipped with asensor that can communicate with a sensor processing component outsidethe endoscope to determine the type of tissue. The sensor may gathertemperature information as well as density information and providesignals corresponding to such information to the sensor processing unit,which can identify the type of tissue being sensed. In someimplementations, the sensor may be an electrical sensor.

In addition, the endoscopic instrument may be equipped with aninjectable dye component through which a physician may mark a particularregion within the patient's body. In other embodiments, the physicianmay mark a particular region utilizing the debriding component, withoutthe use of an injectable dye.

Although the present disclosure discloses various embodiments of anendoscopic instrument, including but not limited to a tool that may beattached to the tip of the endoscope, and a tool that may be fed throughthe length of the endoscope, the scope of the present disclosure is notintended to be limited to such embodiments or to endoscopic instrumentsin general. Rather, the scope of the present disclosure extends to anydevice that may debride and remove polyps from within a patient's bodyusing a single tool. As such, the scope of the present disclosureextends to improved endoscopes that may be built with some or all of thecomponents of the endoscopic instruments described herein. For instance,an improved endoscope with an integrated turbine assembly and configuredto be coupled to a debriding component is also disclosed herein.Furthermore, the endoscope may also include predefined conduits thatextend through the length of the endoscope such that only the suctionconduit may be defined by a disposable tubing, while the air entry andexit conduits and the irrigation conduit are permanently defined withinthe improved endoscope. In other embodiments, the suction conduit isalso predefined but made such that the suction conduit may be cleanedand purified for use with multiple patients. Similarly, the debridingcomponent may also be a part of the endoscope, but also capable of beingcleaned and purified for use with multiple patients. Furthermore, itshould be understood by those skilled in the art that any or all of thecomponents that constitute the endoscopic instrument may be built intoan existing endoscope or into a newly designed endoscope for use indebriding and removing polyps from within the patient's body.

Referring now to FIG. 15, a conceptual system architecture diagramillustrating various components for operating the endoscopic instrumentaccording to embodiments of the present disclosure is shown. Theendoscopic system 1500 includes an endoscope 100 fitted with anendoscopic instrument 220, and which may be coupled to an air supplymeasurement system 1510, an irrigation system 1530 and a polyp removalsystem 1540. As described above, the tubing that extends within theendoscope 100 may include one or more pneumatic air entry conduits 412and one or more pneumatic air exit conduits 414. The pneumatic air entryconduits 412 are coupled to the air supply measurement system 1510,which includes one or more sensors, gauges, valves, and other componentsto control the amount of gas, such as air, being supplied to theendoscope 100 to drive the rotor 440. In some embodiments, the amount ofair being supplied to the rotor 440 may be controlled using the airsupply measurement system 1510. Furthermore, delivery of the air toactuate the rotor 440 may be manually controlled by the physician usingthe endoscope 100. In one embodiment, the physician may use a foot pedalor a hand-actuated lever to supply air to the rotor 440.

The pneumatic air exit conduit 414, however, may not be coupled to anycomponent. As a result, air exiting from the rotor 440 may simply exitthe endoscope via the pneumatic air exit conduit 414 into theatmosphere. In some embodiments, the pneumatic air exit conduit 414 maybe coupled to the air supply measurement system 1510 such that the airexiting the pneumatic air exit conduit 414 is supplied back to the rotorvia the pneumatic air entry conduit 412. It should be appreciated that asimilar setup may be used for a hydraulically driven turbine system.

The endoscope 100 may also be coupled to the irrigation system 1530 viathe irrigation fluid conduit 416. The irrigation system 1530 may includea flow meter 1534 coupled to an irrigation source 1532 for controllingthe amount of fluid flowing from the irrigation source 1532 to theendoscope 100.

As described above, the endoscope 100 may also include a suction conduit418 for removing polyps from within the patient's body. The suctionconduit 418 may be coupled to the polyp removal system 1540, which maybe configured to store the polyps. In various embodiments, the physicianmay be able to collect samples in one or more cartridges 1542 within thepolyp removal system 1540 such that the removed polyps can be testedindividually.

In various embodiments of the present disclosure, an endoscope,comprises a first end and a second end separated by a flexible housing,an instrument channel extending from the first end to the second end,and an endoscopic instrument comprising a debriding component and asample retrieval conduit disposed within the instrument channel. Theendoscopic instrument may further include a flexible tubing in which thesample retrieval conduit is partially disposed, the flexible tubingextending from the first end to the second end of the endoscope. Theflexible tubing may also include a pneumatic air entry conduit and afluid irrigation conduit. In various embodiments, the debridingcomponent may include a turbine assembly and a cutting tool. In variousembodiments in which the endoscope is configured to have a built inendoscopic instrument, the instrument channel may have a diameter thatis larger than the instrument channels of existing endoscopes. In thisway, larger portions of debrided material may be suctioned from withinthe patient's body without clogging the suction conduit.

In other embodiments, an endoscope may include a first end and a secondend separated by a flexible housing; an instrument channel extendingfrom the first end to the second end; and an endoscopic instrumentcoupled to the instrument channel at the first end of the endoscope, theendoscopic instrument comprising a debriding component and a sampleretrieval conduit partially disposed within the instrument channel. Insome embodiments, the endoscopic instrument may be removably attached tothe endoscopic instrument.

In other embodiments of the present disclosure, an endoscopic system,includes an endoscope comprising a first end and a second end separatedby a flexible housing and an instrument channel extending from the firstend to the second end and an endoscopic instrument coupled to theinstrument channel at the first end of the endoscope. The endoscopicinstrument may include a debriding component and a flexible tubinghaving a length that is greater than the length of the endoscope.Moreover, the flexible tubing may include a sample retrieval conduit, anpneumatic air entry conduit, and a fluid irrigation conduit, adisposable cartridge configured to couple with the sample retrievalconduit proximal the second end of the endoscope, a pressurized airsource configured to couple with the pneumatic air entry conduitproximal the second end of the endoscope, and a fluid irrigation sourceconfigured to couple with the fluid irrigation conduit proximal thesecond end of the endoscope. In various embodiments, the endoscope mayalso include at least one camera source and at least one light source.In some embodiments of the present disclosure, the pneumatic air entryconduit supplies pressurized air to a turbine assembly of the debridingcomponent proximal the first end of the endoscope and the fluidirrigation conduit supplies irrigation fluid to the sample retrievalconduit proximal the first end of the endoscope.

FIG. 16A illustrates an exploded partial view of an endoscopicinstrument 1600, which is similar to the endoscopic instrument 150depicted in FIG. 1C in that the endoscopic instrument 1600 is configuredto be inserted within an instrument channel of an endoscope, such as theendoscope 100 depicted in FIG. 1B. FIG. 16B illustrates across-sectional partial view of the endoscopic instrument shown in FIG.16A. As shown in FIGS. 16A and 16B, a head portion of the endoscopicinstrument 1600 can include a powered actuator 1605, a power-driveninstrument head 1680 including a cutting shaft 1610 and an outerstructure 1615 and a feedthrough connector 1620 coupled to a distal endof a flexible tubular member 1630. The flexible tubular member 1630forms the tail portion of the endoscopic instrument 1600. As such, FIGS.16A and 16B illustrate the head portion of the endoscopic instrument1600.

The endoscopic instrument 1600 is configured to define an aspirationchannel 1660 that extends from a proximal end of the flexible tubularmember 1630 to a distal tip 1614 of the power-driven instrument head1680. In some implementations, the proximal end of the flexible tubularmember 1630 may be configured to fluidly couple to a vacuum source. Inthis way, upon the application of a suction force at the proximal end ofthe flexible tubular member 1630, material at or around the distal tip1614 of the power-driven instrument head 1680 can enter the endoscopicinstrument 1600 at the distal tip and flow through the aspirationchannel 1660 all the way to the proximal end of the flexible tubularmember 1630.

The powered actuator 1605 can be configured to drive a power-driveninstrument head 1680, which includes the cutting shaft 1610 disposedwithin the outer structure 1615. In some implementations, the poweredactuator 1605 can include a drive shaft 1608 that is mechanicallycoupled to the cutting shaft 1610. In some implementations, one or morecoupling elements may be used to couple the drive shaft 1608 to aproximal end 1611 of the cutting shaft 1610 such that the cutting shaft1610 is driven by the drive shaft 1608. The powered actuator 1605 can bean electrically powered actuator. In some implementations, theelectrically powered actuator can include an electrical terminal 1606configured to receive an electrical conducting wire for providingelectrical current to the electrically powered actuator 1605. In someimplementations, the electrically powered actuator can include anelectric motor. In some implementations, the electric motor can be amicro-sized motor, such that the motor has an outer diameter of lessthan a few millimeters. In some implementations, the powered actuator1605 has an outer diameter that is smaller than about 3.8 mm. Inaddition to having a small footprint, the powered actuator 1605 may beconfigured to meet certain torque and rotation speed parameters. In someimplementations, the powered actuator 1605 can be configured to generateenough torque and/or rotate at sufficient speeds to be able to cuttissue from within a subject. Examples of motors that meet theserequirements include micromotors made by Maxon Precision Motors, Inc.,located in Fall River, Mass., USA. Other examples of electrical motorsinclude any type of electric motors, including AC motors, DC motors,piezoelectric motors, amongst others.

The power-driven instrument head 1680 is configured to couple to thepowered actuator 1605 such that the powered actuator 1605 can drive thepower-driven instrument head. As described above, the proximal end 1611of the cutting shaft 1610 can be configured to couple to the drive shaft1608 of the powered actuator 1605. The distal end 1614 of the cuttingshaft 1610 opposite the proximal end 1611 can include a cutting tip1612. The cutting tip 1612 can include one or more sharp surfacescapable of cutting tissue. In some implementations, the cutting shaft1610 can be hollow and can define a material entry port 1613 at oraround the cutting tip 1612 through which material that is cut can enterthe endoscopic instrument 1610 via the material entry port 1613. In someimplementations, the proximal end 1611 of the cutting shaft 1610 caninclude one or more outlet holes 1614 that are sized to allow materialflowing from the material entry port 1613 to exit from the cutting shaft1610. As shown in FIGS. 16A and 16B, the outlet holes 1614 are definedwithin the walls of the cutting shaft 1610. In some implementations,these outlet holes 1614 can be sized such that material entering thecutting shaft 1610 via the material entry port 1613 can flow out of thecutting shaft 1610 via the outlet holes 1614. In some implementations,the portion of the cutting shaft 1610 proximal the drive shaft 1608 maybe solid such that all the material that enters the cutting shaft 1610flows out of the cutting shaft 1610 via the outlet holes 1614.

The outer structure 1615 can be hollow and configured such that thecutting shaft can be disposed within the outer structure 1615. As such,the outer structure 1615 has an inner diameter that is larger than theouter diameter of the cutting shaft 1610. In some implementations, theouter structure 1615 is sized such that the cutting shaft 1610 canrotate freely within the outer structure 1615 without touching the innerwalls of the outer structure 1615. The outer structure 1615 can includean opening 1616 at a distal end 1617 of the outer structure 1615 suchthat when the cutting shaft 1610 is disposed within the outer structure1615, the cutting tip 1612 and the material entry port 1613 defined inthe cutting shaft 1610 is exposed. In some implementations, the outersurface of the cutting shaft 1610 and the inner surface of the outerstructure 1615 can be coated with a heat-resistant coating to helpreduce the generation of heat when the cutting shaft 1610 is rotatingwithin the outer structure 1615. A proximal end of the outer structure1615 is configured to attach to the housing that houses the poweredactuator 1605.

The feedthrough connector 1620 can be positioned concentrically aroundthe portion of the cutting shaft 1610 that defines the outlet holes1614. In some implementations, the feedthrough connector 1620 can behollow and configured to enclose the area around the outlet holes 1614of the cutting shaft 1610 such that material leaving the outlet holes1614 of the cutting shaft 1610 is contained within the feedthroughconnector 1620. The feedthrough connector 1620 can include an exit port1622, which can be configured to receive the distal end of the tubularmember 1630. In this way, any material within the feedthrough connector1620 can flow into the distal end of the flexible tubular member 1630.The feedthrough connector 1620 can serve as a fluid coupler that allowsfluid communication between the cutting shaft 1610 and the tubularmember 1630.

The tubular member 1630 can be configured to couple to the exit port1622 of the feedthrough connector 1620. By way of the cutting shaft 160,the feedthrough connector 1620 and the flexible tubular member 1630, theaspiration channel 1660 extends from the material entry port 1613 of thecutting shaft 1610 to the proximal end of the tubular member 1630. Insome implementations, the tubular member 1630 can be configured tocouple to a vacuum source at the proximal end of the tubular member1630. As such, when a vacuum source applies suction at the proximal endof the tubular member 1630, material can enter the aspiration channelvia the material entry port 1613 of the cutting shaft 1610 and flowthrough the aspiration channel 1660 towards the vacuum source and out ofthe endoscopic instrument 1600. In this way, the aspiration channel 1660extends from one end of the endoscopic instrument to the other end ofthe endoscopic instrument 1600. In some implementations, a vacuum sourcecan be applied to the tubular member 1630 such that the material at thetreatment site can be suctioned from the treatment site, through theaspiration channel 1660 and withdrawn from the endoscopic instrument1600, while the endoscopic instrument 1600 remains disposed within theinstrument channel of the endoscope and inside the subject beingtreated. In some implementations, one or more of the surfaces of thecutting shaft 1610, the feedthrough connector 1620 or the tubular member1630 can be treated to improve the flow of fluid. For example, the innersurfaces of the cutting shaft 1610, the feedthrough connector 1620 orthe tubular member 1630 may be coated with a superhydrophobic materialto reduce the risk of material removed from within the patient fromclogging the suction conduit.

Examples of various types of instrument heads that can be coupled to thepowered actuator 1605 are disclosed in U.S. Pat. Nos. 4,368,734,3,618,611, 5,217,479, 5,931,848 and U.S. Pat. Publication 2011/0087260,amongst others. In some other implementations, the instrument head caninclude any type of cutting tip that is capable of being driven by apowered actuator, such as the powered actuator 1650, and capable ofcutting tissue into small enough pieces such that the tissue can beremoved from the treatment site via the aspiration channel definedwithin the endoscopic instrument 1600. In some implementations, thepower-driven instrument head 1680 may be configured to include a portionthrough which material from the treatment site can be removed. In someimplementations, the circumference of the aspiration channel can be inthe order of a few micrometers to a few millimeters.

In some implementations, where the powered actuator 1620 utilizes anelectric current for operation, the current can be supplied via one ormore conductive wires that electrically couple the powered actuator toan electrical current source. In some implementations, the electricalcurrent source can be external to the endoscopic instrument 1600. Insome implementations, the endoscopic instrument 1600 can include anenergy storage component, such as a battery that is configured to supplyelectrical energy to the electrical actuator. In some implementations,the energy storage component can be positioned within the endoscopicinstrument. In some implementations, the energy storage component orother power source may be configured to supply sufficient current to thepowered actuator that cause the powered actuator to generate the desiredamount of torque and/or speed to enable the cutting shaft 1610 to cuttissue material. In some implementations, the amount of torque that maybe sufficient to cut tissue can be greater than or equal to about 2.5 Nmm. In some implementations, the speed of rotation of the cutting shaftcan be between 1000 and 5000 rpm. However, these torque ranges and speedranges are examples and are not intended to be limiting in any manner.

The endoscopic instrument 1600 can include other components or elements,such as seals 1640 and bearings 1625, which are shown. In someimplementations, the endoscopic instrument 1600 can include othercomponents that are not shown herein but may be included in theendoscopic instrument 1600. Examples of such components can includesensors, cables, wires, as well as other components, for example,components for engaging with the inner wall of the instrument channel ofan endoscope within which the endoscopic instrument can be inserted. Inaddition, the endoscopic instrument can include a housing that encasesone or more of the powered actuator, the feedthrough connector 1620, anyother components of the endoscopic instrument 1600. In someimplementations, the tail portion of the endoscopic instrument 1600 canalso include a flexible housing, similar to the flexible portion 165shown in FIG. 1C, that can carry one or more flexible tubular members,such as the flexible tubular member 1630, as well as any other wires,cables or other components.

In some implementations, the endoscopic instrument can be configured toengage with the instrument channel of an endoscope in which theinstrument is inserted. In some implementations, an outer surface of thehead portion of the endoscopic instrument can engage with an inner wallof the instrument channel of the endoscope such that the endoscopicinstrument does not experience any unnecessary or undesirable movementsthat may occur if endoscopic instrument is not supported by theinstrument channel. In some implementations, the head portion of thebody of the endoscopic instrument can include a securing mechanism thatsecures the head portion of the body to the inner wall of the instrumentchannel. In some implementations, the securing mechanism can includedeploying a frictional element that engages with the inner wall. Thefrictional element can be a seal, an o-ring, a clip, amongst others.

FIG. 16C illustrates a schematic view of an engagement assembly of anexample endoscopic instrument. FIG. 16D shows a cut-open view of theengagement assembly when the engagement assembly is disengaged. FIG. 16Eshows a cut-open view of the engagement assembly when the engagementassembly is configured to engage with an instrument channel of anendoscope. As shown in FIGS. 16C and 16D, the engagement assembly 1650includes a housing portion 1652 that defines a cylindrical groove 1654around an outer surface 1656 of the housing portion. The groove 1654 issized such that a compliant seal component 1670 can be partially seatedwithin the groove 1654. A cylindrical actuation member 1660 isconfigured to encompass the housing portion 1652. The cylindricalactuation member 1660 can slidably move along the length of the housingportion 1652. The cylindrical actuation member 1660 is configured toengage the securing member 1670 by pressing on the surface of thesecuring member 1670. The actuation member 1660 can apply a force on thesecuring member 1670 causing the securing member 1670 to deform suchthat the securing member 1670 becomes flatter and wider. The securingmember 1670 is configured such that when the securing member 1670widens, the outer surface of the securing member 1670 can engage with aninner surface of the instrument channel of an endoscope in which theendoscopic instrument is inserted. In this way, when the cylindricalactuation member 1660 is actuated, the endoscopic instrument 1600 canengage with the instrument channel thereby preventing the endoscopicinstrument 1600 from moving relative to the instrument channel. This canhelp provide stability to the operator while treating the subject. Insome implementations, more than one engagement assembly 1650 can bepositioned along various portions of the endoscopic instrument 1600.

FIG. 17A illustrates an exploded view of an example endoscopicinstrument 1700 according to embodiments of the present disclosure. FIG.17B illustrates a cross-sectional view of the endoscopic instrument1700. The endoscopic instrument 1700, similar to the endoscopicinstrument 1600 shown in FIGS. 16A and 16B, can also be configured to beinserted within an instrument channel of an endoscope, such as theendoscope 100 depicted in FIG. 1B. The endoscopic instrument 1700,however, differs from the endoscopic instrument 1600 in that theendoscopic instrument 1700 defines an aspiration channel 1760 thatextends through a powered actuator 1705. In this way, material enteringa material entry port 1713 of the endoscopic instrument 1700 can flowthrough the endoscopic instrument 1700 and out of the endoscopicinstrument in a straight line.

As shown in FIGS. 17A and 17B, the endoscopic instrument 1700 is similarto the endoscopic instrument 1600 except that the endoscopic instrumentincludes a different powered actuator 1705, a different cutting shaft1710 and a different feedthrough connector 1720. The powered actuator1705 is similar to the powered actuator 1605 shown in FIG. 16A butdiffers in that the powered actuator 1705 includes a drive shaft 1708that is hollow and extends through the length of the powered actuator1705. Since some of the components are different, the manner in whichthe endoscopic instrument is assembled is also different.

In some implementations, the powered actuator 1605 can be any actuatorcapable of having a hollow shaft that extends through the length of themotor. The distal end 1708 a of the drive shaft 1708 includes a firstopening and is coupled to the proximal end 1711 of the cutting shaft1705. Unlike the cutting shaft 1610, the cutting shaft 1710 includes afluid outlet hole 1714 at the bottom of the cutting shaft 1710. As aresult, the entire length of the cutting shaft 1710 is hollow. Theproximal end 1708 b of the drive shaft 1708 is configured to couple tothe feedthrough connector 1720, which differs from the feedthroughconnector 1620 in that the feedthrough connector 1720 includes a hollowbore 1722 defining a channel in line with the proximal end of the driveshaft such that the drive shaft 1708 and the hollow bore 1722 arefluidly coupled. The hollow bore 1722 can be configured to couple to theflexible tubular member 1730, which like the flexible tubular member1630, extends from the feedthrough connector at a distal end to aproximal end that is configured to couple to a vacuum source.

As shown in FIGS. 17A and 17B, the drive shaft 1708 can be hollow, suchthat the drive shaft 1708 defines a first opening at a distal end 1708 aand a second opening at a proximal end 1708 b of the drive shaft 1708.The cutting shaft 1710 is also hollow and defines an opening 1714 at thebottom end 1710 a of the cutting shaft 1710. The distal end 1708 a ofthe drive shaft 1708 is configured to couple to the bottom end 1710 a ofthe cutting shaft 1710 such that the first opening of the drive shaft1708 is aligned with the opening at the bottom end 1710 a of the cuttingshaft 1710. In this way, the drive shaft 1708 can be fluidly coupled tothe cutting shaft 1710. A distal end 1710 b of the cutting shaft 1710includes a cutting tip 1712 and the material entry port 1713.

The proximal end 1708 a of the drive shaft 1708 is fluidly coupled to adistal end of the flexible tubular member 1730 via the feedthroughconnector 1720. In some implementations, the feedthrough connector 1720couples the drive shaft and the flexible tubular member such that theflexible tubular member does not rotate with the drive shaft. Theproximal end of the flexible tubular member can be configured to coupleto a vacuum source.

As shown in FIG. 17B, the endoscopic instrument 1700 defines anaspiration channel 1760 that extends from the material entry port 1713through the cutting shaft, the drive shaft, the feedthrough connector1720 to the second end of the flexible tubular member 1730. In this way,material that enters the material entry port 1713 can flow through thelength of the endoscopic instrument and exit from the endoscopicinstrument at the second end of the endoscopic instrument.

Other components of the endoscopic instrument 1700 are similar to thoseshown in the endoscopic instrument 1600 depicted in FIGS. 16A and 16B.For example, the outer structure 1715, the encoding component 1606, theseals and the bearings may be substantially similar to the outerstructure 1615, the encoding component 1606, the seals 1640 and thebearings 1625 depicted in FIG. 16. Other components, some of which areshown, may be included to construct the endoscopic instrument and forproper functioning of the instrument.

FIG. 18A illustrates an exploded view of an example endoscopicinstrument 1800 according to embodiments of the present disclosure. FIG.18B illustrates a cross-sectional view of the endoscopic instrument1800. The endoscopic instrument 1800, similar to the endoscopicinstrument 1700 shown in FIGS. 17A and 17B, can also be configured to beinserted within an instrument channel of an endoscope, such as theendoscope 100 depicted in FIG. 1B. The endoscopic instrument 1800,however, differs from the endoscopic instrument 1700 in that theendoscopic instrument 1800 includes a pneumatic or hydraulically poweredactuator 1805.

In some implementations, the powered actuator 1802 includes a teslaturbine that includes a tesla rotor 1805, a housing 1806 and a connector1830 that along with the housing 1806 encases the tesla rotor 1805. Thetesla rotor 1805 can include a plurality of disks 1807 spaced apart andsized such that the tesla rotor 1805 fits within the housing. In someimplementations, the tesla rotor can include between 7 and 13 diskshaving a diameter between about 2.5 mm and 3.5 mm and thicknessesbetween 0.5 mm to 1.5 mm. In some implementations, the disks areseparated by gaps that range from 0.2 mm to 1 mm. The tesla turbine 1802also can include a hollow drive shaft 1808 that extends along a centerof the tesla rotor 1805. In some implementations, a distal end 1808 a ofthe drive shaft 1808 is configured to be coupled to a cutting shaft 1810such that the cutting shaft 1810 is driven by the tesla rotor. That is,in some implementations, the cutting shaft 1810 rotates as the driveshaft 1808 of the tesla rotor 1805 is rotating. In some implementations,the cutting shaft 1810 can include outlet holes similar to the cuttingshaft 1610 shown in FIG. 16A. In some such implementations, thefeedthrough connector fluidly couples the cutting shaft and the flexibleportion similar to the feedthrough connector 1630 shown in FIG. 16A.

The connector 1830 of the tesla turbine 1802 can include at least onefluid inlet port 1832 and at least one fluid outlet port 1834. In someimplementations, the fluid inlet port 1832 and the fluid outlet port1834 are configured such that fluid can enter the tesla turbine 1802 viathe fluid inlet port 1832, cause the tesla rotor 1805 to rotate, andexit the tesla turbine 1802 via the fluid outlet port 1834. In someimplementations, the fluid inlet port 1832 is fluidly coupled to a fluidinlet tubular member 1842 configured to supply fluid to the tesla rotorvia the fluid inlet port 1832. The fluid outlet port 1834 is fluidlycoupled to a fluid outlet tubular member 1844 and configured to removethe fluid supplied to the tesla turbine 1802. The amount of fluid beingsupplied and removed from the tesla turbine 1802 can be configured suchthat the tesla rotor 1805 can generate sufficient torque, while rotatingat a sufficient speed to cause the cutting shaft 1810 to cut tissue at atreatment site. In some implementations, the fluid can be air or anyother suitable gas. In some other implementations, the fluid can be anysuitable liquid, such as water. Additional details related to how fluidcan be supplied or removed from pneumatic or hydraulic actuators, suchas the tesla turbine 1802 has been described above with respect to FIGS.4A-15.

The connector 1830 also includes a suction port 1836 that is configuredto couple to an opening defined at a proximal end 1808 b of the hollowdrive shaft 1808. The suction port 1836 is further configured to coupleto a distal end of a flexible tubular member 1846, similar to theflexible tubular member 1730 shown in FIG. 17A, which is configured tocouple to a vacuum source at a proximal end. In some implementations, aflexible tubular housing can include one or more of the fluid inlettubular member 184, fluid outlet tubular member 1844 and the flexibletubular member 1846. In some implementations, the flexible tubularhousing can include other tubular members and components that extendfrom the head portion of the endoscopic instrument to the proximal endof the tail portion of the endoscopic instrument 1800.

The cutting shaft 1810 and an outer structure 1815 are similar to thecutting shaft 1710 and the outer structure 1715 of the endoscopicinstrument 1700 depicted in FIG. 17A. The cutting shaft 1810 is hollowand defines an opening at a proximal end 1810 b of the cutting shaft1810. The proximal end 1810 b of the cutting shaft 1810 is configured tocouple to a distal end 1808 a of the drive shaft 1808 such that anopening at the distal end 1808 a of the drive shaft 1808 is aligned withthe opening defined at the proximal end 1808 b of the cutting shaft1810. In this way, the drive shaft 1808 can be fluidly coupled to thecutting shaft 1810. A distal end 1810 b of the cutting shaft 1810includes a cutting tip 1812 and a material entry port 1813 similar tothe cutting shafts 1610 and 1710 shown in FIGS. 16A and 17A.

In some implementations, an irrigation opening 1852 can be formed in thehousing 1806. The irrigation opening 1852 is configured to be fluidlycoupled to the aspiration channel 1860. In some such implementations,the irrigation opening 1852 is configured to be fluidly coupled to a gap(not clearly visible) that separates the walls of outer structure 1815and the cutting shaft 1810. In this way, fluid supplied to the teslaturbine 1802 can escape via the irrigation opening 1852 in to the gap.The fluid can flow towards the material entry port 1813 of the cuttingshaft 1810, through which the fluid can enter the aspiration channel1860. In some implementations, since the aspiration channel 1860 isfluidly coupled to a vacuum source, the fluid from the tesla turbine1802 can be directed to flow through the aspiration channel 1860 asirrigation fluid along with any other material near the material entryport 1813. In this way, the irrigation fluid can irrigate the aspirationchannel 1860 to reduce the risk of blockages.

In addition, as the irrigation fluid flows in the gap separating theouter structure 1815 and the cutting shaft 1810, the irrigation fluidcan serve to reduce the generation of heat. In some implementations, oneor both of the cutting shaft 1810 and the outer structure 1815 can becoated with a heat-resistant layer to prevent the cutting shaft and theouter structure from getting hot. In some implementations, one or bothof the cutting shaft 1810 and the outer structure 1815 can be surroundedby a heat-resistant sleeve to prevent the cutting shaft 1810 and theouter structure 1815 from getting hot.

In some implementations, other types of hydraulically or pneumaticallypowered actuators can be utilized in place of the tesla turbine. In someimplementations, a multi-vane rotor can be used. In some suchimplementations, the powered actuator can be configured to be fluidlycoupled to a fluid inlet tubular member and a fluid outlet tubularmember similar to the tubular members 1842 and 1844 shown in FIG. 18B.

As described above with respect to the endoscopic instruments 1600, 1700and 1800 depicted in FIGS. 16A, 17A and 18A, an endoscopic instrument isconfigured to meet certain size requirements. In particular, theendoscopic instrument can be long enough such that when the endoscopicinstrument is completely inserted into the endoscope, the power-driveninstrument head can extend beyond the face of the endoscope at one endsuch that the cutting tip is exposed, while the tail portion of theendoscopic instrument can extend out of the other end of the endoscopesuch that the tail portion can be coupled to a vacuum source. As such,in some implementations, the endoscopic instrument may be configured tobe longer than the endoscopes in to which the endoscopic instrument willbe inserted. Further, since endoscopes have instrument channels thathave different diameters, the endoscopic instrument may also beconfigured to have an outer diameter that is sufficiently small suchthat the endoscopic instrument can be inserted into the instrumentchannel of the endoscope in to which the endoscopic instrument will beinserted.

Some endoscopes, such as colonoscopes, can have instrument channels thathave an inner diameter that can be as small as a few millimeters. Insome implementations, the outer diameter of the endoscopic instrumentcan be less than about 3.2 mm. As such, powered actuators that are partof the endoscopic instrument may be configured to have an outer diameterthan is less than the outer diameter of the endoscopic instrument. Atthe same time, the powered actuators may be configured to be able togenerate sufficient amounts of torque, while rotating at speedssufficient to cut tissue at a treatment site within a subject.

In some other implementations, the endoscopic instrument can beconfigured such that a powered actuator is not housed within theendoscopic instrument at all or at least within a portion of theendoscopic instrument that can be inserted within the instrument channelof an endoscope. Rather, the endoscopic instrument includes a flexiblecable that is configured to couple a power-driven instrument head of theendoscopic instrument to a powered actuator that is located outside ofthe endoscope.

FIG. 19A illustrates an example endoscopic instrument 1900 that iscoupled to a powered actuation and vacuum system 1980. The endoscopicinstrument includes a head portion 1902 and a tail portion. The tailportion includes the flexible cable 1920, which can provide torque tothe head portion 1902. The powered actuation and vacuum system 1980includes a powered actuator 1925, a coupler 1935 and a vacuum tubing1930 configured to couple to the couple 1935 at a first end 1932 andcouple to a vacuum source at a second end 1934. In some implementations,the flexible cable 1920 can be hollow and configured to carry fluid fromthe head portion 1902 to the coupler 1935.

FIG. 19B illustrates a cross-section view of the powered actuation andvacuum system 1980 of FIG. 19A. The powered actuator 1925 includes adrive shaft 1926 that is mechanically coupled to a proximal end 1922 ofthe flexible cable 1920. In some implementations, the drive shaft 1926and the flexible cable 1920 are mechanically coupled via the coupler1935. The coupler 1935 includes a vacuum port 1936 to which a first end1932 of the vacuum tubing 1930 can be fluidly coupled. The coupler 1935can be enclosed such that the vacuum tubing 1930 and the flexible cableare fluidly coupled. In this way, suction applied in the vacuum tubing1930 can be applied all the way through the flexible cable 1920 to thehead portion 1902 of the endoscopic instrument 1900. Further, anymaterial that is in the flexible cable 1920 can flow through theflexible cable to the vacuum tubing 1930 via the coupler 1935. In someimplementations, the coupling between the flexible cable and the vacuumtubing can occur within the head portion 1902. In such implementations,the coupler 1935 may be configured to be small enough to be positionedwithin the head portion 1902.

FIG. 19C illustrates an exploded view of an example head portion of theendoscopic instrument 1900 shown in FIG. 19A. The head portion includesa housing cap 1952, a collet 1954, a cutting shaft 1956, a shaft coupler1958 and a head portion housing 1960. In some implementations, thecollet 1954 is slightly tapered towards a distal end such that thecollet 1954 can couple with the cutting shaft 1956 that is disposedwithin the collet 1954. The shaft coupler 1958 is configured to couplethe cutting shaft to the distal end of the flexible cable 1920. The headportion 1960 and the housing cap 1952 are configured to house the shaftcoupler 1958.

FIG. 19D illustrates a cut-open view of a portion of the endoscopicinstrument 1900 having an engagement assembly. In some implementations,the head portion housing 1960 can include an engagement assembly forengaging with the inner walls of an instrument channel. The engagementassembly can be similar to the engagement assembly 1650 shown in FIG.16C. In some implementations, the engagement assembly can be actuatedvia a vacuum source. FIG. 19E shows a cut-open view of the engagementassembly shown in FIG. 19D in a disengaged position. FIG. 19F shows acut-open view of the engagement assembly shown in FIG. 19D in an engagedposition.

The engagement assembly can include a pair of vacuum actuated members1962 that are configured to rotate between an extended position in whichthe members 1962 are extended outwardly to engage with a wall of theinstrument channel 1990 and a retracted position in which the members1962 are positioned such that they lie substantially parallel to thewalls of the instrument channel 1990. The grooves 1964 are fluidlycoupled to an aspiration channel 1970 defined within the flexible cable1920. In some implementations, fluid channels 1966 fluidly couple thegrooves 1964 to the aspiration channel 1970. When a vacuum source isapplied to the aspiration channel 1970, a suction force is applied tothe members 1962 causing them to move from a retracted position (asshown in FIG. 19E) to an extended position (as shown in FIG. 19F). Insome implementations, the engagement assembly can also include an outerring supported by the vacuum actuated members 1964. The outer ring 1966can be configured to assist in guiding the endoscopic instrument throughthe instrument channel of the endoscope. In particular, the outer ringcan prevent the endoscopic instrument from tilting to one side causingthe power-driven instrument head from jarring against the instrumentchannel.

The endoscopic instrument 1900 is similar to the endoscopic instruments1600, 1700 and 1800 depicted in FIGS. 16A-18A respectively but differsfrom them in that the endoscopic instrument 1900 does not include apowered actuator within the head portion 1902 of the endoscopicinstrument 1900. Instead, the endoscopic instrument 1900 includes aflexible cable 1920 for providing torque to a power-driven instrumenthead 1904 of the endoscopic instrument 1900. In some implementations,the power-driven instrument head 1904 can be similar to the power-driveninstrument heads depicted in FIGS. 16A-18A. In some implementations, theflexible cable 1920 can be hollow such that fluid can flow through theflexible cable 1920. In some such implementations, a proximal end 1922of the flexible cable 1920 can be configured to couple to a vacuumsource, while a distal end 1921 of the flexible cable 1920 can becoupled to the power-driven instrument head 1904. In this way, fluidthat enters a material entry port 1907 can flow through the power-driveninstrument head 1904 and into the flexible cable 1920, from which thefluid can flow through the flexible cable 1920 and be removed from theendoscopic instrument 1900 at the proximal end 1922 of the flexiblecable 1920.

In some implementations, a flexible cable, such as the flexible cable1920 can replace a powered actuator and drive shaft that are housedwithin an endoscopic instrument. For example, the endoscopic instruments1600, 1700 and 1800 depicted in FIGS. 16A, 17A and 18A can be configuredto utilize a flexible cable that is coupled to a cutting shaft of apower-driven instrument head at a distal end and coupled to a poweredactuator located outside the endoscopic instrument at a proximal end.The powered actuator located outside the endoscopic instrument may besignificantly larger than the powered actuators 1605, 1705 or 1805. Asthe powered actuator is actuated, torque generated by the poweredactuator can be translated from the powered actuator to the power-driveninstrument head via the flexible cable. The flexible cable 1920 isconfigured to translate torque from the powered actuator to the cuttingshaft. In some implementations, the flexible cable 1920 is or includes afine coil with multiple threads and multiple layers, which can transmitthe rotation of one end of the flexible cable to an opposite end of theflexible cable. The flexibility of the cable allows the coil to maintainperformance even in sections of the coil that are bent. Examples of theflexible cable 1920 include torque coils made by ASAHI INTECC USA, INClocated in Santa Ana, Calif., USA. In some implementations, the flexiblecable 1920 can be surrounded by a sheath to avoid frictional contactbetween the outer surface of the flexible cable and other surfaces. Insome implementations, the flexible cable 1920 can be coated withPolytetrafluoroethylene (PFTE) to reduce frictional contact between theouter surface of the flexible cable and other surfaces.

FIG. 20 is a conceptual system architecture diagram illustrating variouscomponents for operating the endoscopic instrument according toembodiments of the present disclosure. The endoscopic system 2000includes an endoscope 100 fitted with an endoscopic instrument 2002 thatincludes a flexible tail portion 2004. The endoscopic instrument can,for example, be the endoscopic instrument 220, 1600, 1700, 1800 or 1900shown in FIGS. 4A-14, 16A, 17A, 18A and 19A. The system also includes anendoscope control unit 2005 that controls the operation of the endoscope100 and an instrument control unit 2010 that controls the operation ofthe endoscopic instrument 2002.

In addition, the endoscopic instrument also includes a vacuum source1990, a sample collection unit 2030 and a tissue sensing module 2040.The vacuum source 1990 is configured to fluidly couple to a flexibletubular member that forms a portion of the aspiration channel. In thisway, material that flows from the endoscopic instrument through theaspiration channel towards the vacuum source 1990 can get collected at2030 sample collection unit. The tissue sensing module can becommunicatively coupled to a tissue sensor disposed at a distal tip ofthe endoscopic instrument 2000. In some such implementations, the tissuesensing module can also be configured to be communicatively coupled tothe instrument control unit 2010 such that the tissue sensing module cansend one or more signals instructing the control unit 2010 to stop theactuation of the powered actuator.

In some implementations in which the powered actuator is electricallyactuated and disposed within the endoscopic instrument, the poweredactuator can be electrically coupled to the instrument control unit2010. In some such implementations, the powered actuator is coupled tothe control unit via one or more electric cables. In someimplementations, the powered actuator may be battery operated in whichcase, the tubing may include cables extending from the control unit tothe powered actuator or the battery for actuating the powered actuator.

In some implementations in which the power-driven instrument head iscoupled to a flexible torque coil that couples the power-driveninstrument head to a powered actuator that resides outside of theendoscope, the powered actuator can be a part of the instrument controlunit.

In various embodiments of the present disclosure, an endoscope,comprises a first end and a second end separated by a flexible housing,an instrument channel extending from the first end to the second end,and an endoscopic instrument comprising a debriding component and asample retrieval conduit disposed within the instrument channel. Theendoscopic instrument may further include a flexible tubing in which thesample retrieval conduit is partially disposed, the flexible tubingextending from the first end to the second end of the endoscope. Theflexible tubing may also include a pneumatic air entry conduit and afluid irrigation conduit. In various embodiments, the debridingcomponent may include a turbine assembly and a cutting tool. In variousembodiments in which the endoscope is configured to have a built inendoscopic instrument, the instrument channel may have a diameter thatis larger than the instrument channels of existing endoscopes. In thisway, larger portions of debrided material may be suctioned from withinthe patient's body without clogging the suction conduit.

In other embodiments, an endoscope may include a first end and a secondend separated by a flexible housing; an instrument channel extendingfrom the first end to the second end; and an endoscopic instrumentcoupled to the instrument channel at the first end of the endoscope, theendoscopic instrument comprising a debriding component and a sampleretrieval conduit partially disposed within the instrument channel. Insome embodiments, the endoscopic instrument may be removably attached tothe endoscopic instrument.

In other embodiments of the present disclosure, an endoscopic system,includes an endoscope comprising a first end and a second end separatedby a flexible housing and an instrument channel extending from the firstend to the second end and an endoscopic instrument coupled to theinstrument channel at the first end of the endoscope. The endoscopicinstrument may include a debriding component and a flexible tubinghaving a length that is greater than the length of the endoscope.Moreover, the flexible tubing may include a sample retrieval conduit, anpneumatic air entry conduit, and a fluid irrigation conduit, adisposable cartridge configured to couple with the sample retrievalconduit proximal the second end of the endoscope, a pressurized airsource configured to couple with the pneumatic air entry conduitproximal the second end of the endoscope, and a fluid irrigation sourceconfigured to couple with the fluid irrigation conduit proximal thesecond end of the endoscope. In various embodiments, the endoscope mayalso include at least one camera source and at least one light source.In some embodiments of the present disclosure, the pneumatic air entryconduit supplies pressurized air to a turbine assembly of the debridingcomponent proximal the first end of the endoscope and the fluidirrigation conduit supplies irrigation fluid to the sample retrievalconduit proximal the first end of the endoscope.

As described above with respect to FIGS. 19A-19C, the endoscopic toolcan include a flexible cable that can be configured to be driven by apowered actuator that resides outside the endoscopic tool itself. Theflexible cable can be a torque coil or rope.

FIGS. 21AA-21F illustrate aspects of an endoscopic assembly. Inparticular, Figures FIGS. 21AA-21F illustrate various views of anendoscopic tool 2110 coupled to a powered actuator 2120 encased in ahousing 2150. As shown in FIG. 21, the powered actuator 2120 can be amotor that is operatively coupled to a flexible cable via a pulleysystem. A casing 2150 including one or more structures, such as a baseplate 2152, one or more side plates 2154 and a top plate 2156 can encasethe motor 2120. A coupling component 2130 can be configured to couplethe flexible cable 2114 to the motor 2120, while providing a suctionmechanism to remove any fluids passing through the endoscopic tool 2110.The coupling component 2130 can include a suction port 2170 throughwhich fluid within the endoscopic tool 2110 can be removed andcollected. In FIG. 21B, a pair of pulleys 2160 and 2162 coupled to atiming belt 2164 are configured such that rotational energy from themotor is transferred to one end of the flexible cable 2114. The otherend of the flexible cable 2114 can be coupled to a cutting member 2112.Additional details regarding the flexible cable 2114 are describedherein with respect to FIGS. 22A-22H.

FIGS. 22A-22H show various implementations of example flexible cables.In some implementations, the flexible cable can be made of threeseparate threads or wires. An inner wire can have a left-hand wound, amiddle wire can have a right-hand wound and the outer wire can have aleft-hand wound. In some implementations, the inner wire can have aright-hand wound, a middle wire can have a left-hand wound and the outerwire can have a right-hand wound. In some implementations, the flexiblecable can be made of two separate threads or wires. In some suchimplementations, the inner wire can have a left-hand wound and the outerwire can have a right-hand wound. In some other implementations, theinner wire can have a right-hand wound and the outer wire can have aleft-hand wound. In some implementations, the wirerope strands can betwisted in either Z-lay or S-lay. Examples of flexible cables includewireropes and torque coils manufactured by ASAHI INTECC. In someimplementations, the outer diameter of the torque rope or coil islimited by the size of the working channel of the endoscope with whichthe endoscopic tool will be used. Other size considerations that need tobe taken into account include providing enough space for the aspirationchannel, irrigation channel, amongst others. In some implementations,the outer diameter of the torque coil or torque rope can range between0.1 mm and 4 mm. In some implementations, the torque coil or rope canhave an outer diameter of 0.5 mm to 2.0 mm.

Referring back to FIG. 21D, a cross-sectional view of the couplingcomponent 2130 is shown. The coupling component 2130 couples one end ofthe endoscopic tool to the powered actuator 2120 via the pulleys 2160and 2162 and to the suction port 2170. The coupling component includes acollection chamber 2181, which is where fluid within the aspirating tube2118 of the endoscopic tool 2110 can be collected before being suctionedout from the coupling component 2130. The coupling component includes acollection chamber 2181 can also include a drive shaft 2186 that isconfigured to engage with the pulley 2162. The flexible cable or torquerope 2114 can be coupled to one end of the drive shaft 2186. An oppositeend of the drive shaft 2186 is coupled to the pulley 2162, such that thedrive shaft is operatively coupled with the motor 2120. In this way, asthe motor rotates, the pulleys and the timing belt 2164 are configuredto rotate the drive shaft 2186, and in turn, the torque rope 2114. FIGS.24A-24C illustrate various aspects of the drive shaft of the couplingcomponent 2130. As shown in FIGS. 24A-24C, the drive shaft 2186 can beconfigured to receive one end of the flexible cable via an opening 2406.A pair of holes 2402 a and 2402 b can be configured to receive setscrews or other securing members for securing the flexible cable to thedrive shaft 2186.

The coupling component 2130 also includes a housing component 2500 thatcouples a flexible portion of the endoscopic tool to the suction port2170 via an opening 2502. FIG. 25 illustrates an example housingcomponent 2500.

FIGS. 26A-26E show an example sleeve bearing.

FIGS. 27A-27C show an example base plate 2152 that forms a portion ofthe casing. FIGS. 28A-28D show an example side plate that forms aportion of the casing. The side plate can also serve as a feedthroughmount.

In some implementations, the coupling component is a part of theendoscopic tool. In some implementations, the coupling component iscoupled to a flexible portion of the endoscopic tool via a compressionfitting component 2182.

The flexible portion of the endoscopic tool includes an outer tubing,which includes an aspiration tube 2118, the torque rope 2114 and asheath 2116 that surrounds the outer circumference of the torque rope2114. The sheath can help reduce friction or the formation of kinks. Theaspiration tube 2118 is configured to couple to a cutting tool 2190 suchthat material that enters into the cutting tool 2190 via an opening 2193can pass through the length of the endoscopic tool 2110 via theaspiration tube 2118.

As shown in FIGS. 21E-21F, the torque rope is configured to be coupledto an inner cannula 2192 that forms a portion of the cutting tool. Theinner cannula 2192 can be surrounded by or disposed within the outercannula 2191. The opening 2193 is formed within the outer cannula 2191at one end of the cutting tool 2190. Details of the cutting tool 2190have been provided herein. Figures FIGS. 23AA-23BB show an exampleimplementation of a cutting tool. The cutting tool can be any type ofcutting tool used in existing medical devices. The cutting tool shown inFigures FIGS. 23AA-23BB are shown only for the sake of example and thepresent disclosure is not intended to be limited to such sizes, shapes,or dimension. Commercially available cutting tools can be used. In someimplementations, the cutting tools can be modified in length. In someimplementations, the inner cannula can be bonded to the ferrule, whilethe outer cannula can be coupled to the outer aspirating tube. In someimplementations, the connection between the outer cannula and theaspiration channel may be sealed to prevent material from leakingthrough the connection.

In some implementations, the torque rope 2114 is coupled to the innercannula 2192 via a ferrule 2194. The ferrule can be a component thatcouples the torque rope to the inner cannula such that rotational energywithin the torque rope is transferred to the inner cannula. Additionaldetails regarding the shape, size and dimensions of the ferrule areshown in FIGS. 29AA-29EE. Depending on the size of the torque rope orflexible cable used in the endoscopic tool 2110, the shape and size ofthe ferrule may vary. Further, the ferrules shown in FIGS. 29A-29E aremerely shown for the sake of example and are not intended to be limitedto the particular size, shape, or dimensions shown in the Figures. Insome implementations, the ends of the torque rope can be inserted intoand bonded to short lengths of hypodermic tubing. Doing so can make iteasier to attach the ferrule to the distal end, and to clamp onto on theproximal end (towards the drive shaft). In some implementations, agraphite filled cyanoacrylate, such as loctite black max, can be used.Other similar types of materials can also be used instead.

FIGS. 30AA-30C illustrate aspects of an endoscopic assembly in which thetip is press-fit. In some implementations, the flexible portion of theendoscopic tool can include a balloon structure that can be deployedsuch that the balloon structure can engage with the inner walls of theendoscope. The balloon structure can be coupled to an air supply line3006 that is coupled to an air supply source, such that when air issupplied, the balloon can expand and engage with the inner wall of theendoscope. In some implementations, the balloon structure can expandasymmetrically, as shown in FIG. 30AA-30AB. In some implementations, theair supply source can be actuated via a foot pedal. An irrigation line3002 can be configured to supply an irrigation fluid. The irrigationfluid can flow towards the cutting tool, where the irrigation fluid canthen flow through the suction channels 3004. The irrigation fluid canprevent the suction channels from blockages. As shown in FIG. 30C, theflexible cable or torque rope can be press fit into a button at one endof the cutting tool.

FIGS. 31AA-31AB and 31B-31C illustrate aspects of an endoscopic assemblyin which the tip is press-fit. In some implementations, the flexibleportion of the endoscopic tool can include a balloon structure that canbe deployed such that the balloon structure can engage with the innerwalls of the endoscope. The balloon structure can be coupled to an airsupply source such that when air is supplied, the balloon can expand andengage with the inner wall of the endoscope. In some implementations,the balloon structure can expand symmetrically, as shown in FIGS. 31AAand 31AB. An irrigation line can be configured to supply an irrigationfluid. The irrigation fluid can flow towards the cutting tool, where theirrigation fluid can then flow through the suction channels. Theirrigation fluid can prevent the suction channels from blockages. Asshown in FIG. 31C, the flexible cable or torque rope can be welded toone end of the cutting tool.

FIG. 32 shows a top view of an example flexible portion of an endoscopictool. In some implementations, the flexible portion shown in FIG. 32 canbe used with the implementations shown in FIGS. 30AA-30C and 31AA-31ABand 31B-31C. The flexible portion 3202 includes a center channel 3204through which the flexible cable passes through. The flexible portion3202 also includes two aspiration channels 3406 a and 3406 b, anirrigation channel 3408 and an air supply channel 3410.

In some implementations, the operating speed of the torque rope canvary. In some example implementations, the torque rope can have anoperating speed within the range of 0.5 k RPM to 20 k RPM. In someimplementations, the torque rope can have an operating speed within therange of 1 k RPM and 4 k RPM. In some implementations, the operatingspeed of the torque rope can vary. In some example implementations, thetorque rope can operate with a torque of 5 to 100 mN*m (milliNewtonMeters). In some implementations, the torque rope can operate with atorque of 20 to 50 mN*m (milliNewton Meters). However, it should beappreciated by those skilled in the art that the torque and runningspeed of the flexible cable can be altered based on the performance ofthe endoscopic tool. In some implementations, various factors contributeto the performance of the endoscopic tool, including the amount ofsuction, the type of cutter, the size of the opening in the cutter,amongst others. As such, the torque and running speed at which tooperate the flexible cable can be dependent on a plurality of factors.

FIG. 33 is a cross-sectional view of an example cutting assembly of anendoscopic tool using a torque rope. The cutting assembly 3300 includesan outer cannula 3302, an inner cannula 3304 including an inner cutter3306 disposed within the outer cannula 3302, a PTFE bearing 3308, asemi-compliant balloon 3310, and a multilumen extrusion 3312. A torquerope 3314 can be coupled to the inner cutter 3306. The diameter of theouter cannula can be between 0.05 inches to a size suitable to passthrough an instrument channel of an endoscope.

FIGS. 35AA-35AC show are cross-sectional views of differentconfigurations of the flexible portion region of one implementation ofan endoscopic tool described herein. The flexible portion region caninclude an aspiration lumen 3402, an inflation lumen 3404, a lavage orirrigation lumen 3406 and a torque rope.

FIG. 35 shows various views of portions of an endoscopic tool. Theendoscopic tool can include an outer cannula 1, an inner cutter 2, aninner cannula 3, a torque rope 4, a trilumen extrusion 5, a balloon 6, aPTFE washer 7, two sidearms 8, a proximal plug 9, an PTFE gasket 10 anda gasket cap 11.

FIG. 36 shows a cross-sectional view of the flexible portion region ofone implementation of an endoscopic tool described herein. The flexibleportion region can include an outer inflation jacket 3602, an outer coil3604, a torque coil 3606, a multi-lumen extrusion 3608 disposed withinthe torque coil. The multi-lumen extrusion 3608 can include a lavagelumen 3610 and an aspiration lumen 3612.

FIG. 37 shows a cross-section view of one implementation of theendoscopic tool described herein. The endoscopic tool includes an outercannula 3702, an inner cutter 3704, an inner torque coil 3706, an outercoil 3708, an outer inflation jacket and balloon 3710, and a multi-lumenextrusion 3712. A gear 3714, such as a worm gear can engage with thetorque coil to drive the inner cutter.

FIGS. 38A and 38B show various views of a distal portion of oneimplementation of an endoscopic tool described herein. The endoscopictool includes an outer cutter 3802 that defines an opening 3804. Theendoscopic tool also includes an inner cutter 3806 disposed within theouter cutter. The inner cutter is coupled to a torque coil 3808. Thetorque coil is disposed within a PET heat shrink 3810 or other type oftubing. The outer cutter is coupled to a braided shaft 3812 to allow theouter cutter 3802 to rotate relative to the inner cutter 3806.

FIGS. 39A and 39B show cross-sectional views of the distal portion ofthe endoscopic tool shown in FIGS. 38A and 38B along the sections B-Band sections C-C.

In some implementations, an endoscopic instrument insertable within asingle instrument channel of an endoscope can include a power driveninstrument head or cutting assembly that is configured to resectmaterial at a site within a subject. The cutting assembly includes anouter cannula and an inner cannula disposed within the outer cannula.The outer cannula defines an opening through which material to beresected enters the cutting assembly. The endoscopic instrument alsoincludes a flexible outer tubing coupled to the outer cannula andconfigured to cause the outer cannula to rotate relative to the innercannula. The flexible outer tubing can have an outer diameter that issmaller than the instrument channel in which the endoscopic instrumentis insertable. The endoscopic instrument also includes a flexible torquecoil having a portion disposed within the flexible outer tubing. Theflexible torque coil having a distal end coupled to the inner cannula.The flexible torque coil is configured to cause the inner cannula torotate relative to the outer cannula. The endoscopic instrument alsoincludes a proximal connector coupled to a proximal end of the flexibletorque coil and configured to engage with a drive assembly that isconfigured to cause the proximal connector, the flexible torque coil andthe inner cannula to rotate upon actuation. The endoscopic instrumentalso includes an aspiration channel having an aspiration port configuredto engage with a vacuum source. The aspiration channel is partiallydefined by an inner wall of the flexible torque coil and an inner wallof the inner cannula and extends from an opening defined in the innercannula to the aspiration port. The endoscopic instrument also includesan irrigation channel having a first portion defined between an outerwall of the flexible torque coil and an inner wall of the flexible outertubing and configured to carry irrigation fluid to the aspirationchannel.

In some implementations, the proximal connector is hollow and an innerwall of the proximal connector defines a portion of the aspirationchannel. In some implementations, the proximal connector is a rigidcylindrical structure and is configured to be positioned within a drivereceptacle of the drive assembly. The proximal connector can include acoupler configured to engage with the drive assembly and a tensioningspring configured to bias the inner cannula towards a distal end of theouter cannula. In some implementations, the tensioning spring is sizedand biased such that the tensioning spring causes a cutting portion ofthe inner cannula to be positioned adjacent to the opening of the outercannula. In some implementations, the proximal connector is rotationallyand fluidly coupled to the flexible torque coil. In someimplementations, the tensioning spring can be sized and biased such thatthe distal tip of the inner cannula can contact the inner distal wall ofthe outer cannula. This may limit any lateral or undesired movementgenerated due to whip at the distal end of the inner cannula caused bythe rotation of the flexible torque coil.

In some implementations, the endoscopic instrument also includes alavage connector including an irrigation entry port and a tubular membercoupled to the lavage connector and the flexible outer tubing. An innerwall of the tubular member and the outer wall of the flexible torquecoil can define a second portion of the irrigation channel that isfluidly coupled to the first portion of the irrigation channel. In someimplementations, the endoscopic instrument also includes a rotationalcoupler coupling the flexible outer tubing to the tubular member andconfigured to cause the flexible outer tubing to rotate relative to thetubular member and cause the opening defined in the outer cannula torotate relative to the inner cannula. In some implementations, thelavage connector defines an inner bore within which the flexible torquecoil is disposed.

In some implementations, the endoscopic instrument also includes alining within which the flexible torque coil is disposed, the outer wallof the lining configured to define a portion of the irrigation channel.In some implementations, the inner cannula is configured to rotate abouta longitudinal axis of the inner cannula and relative to the outercannula and the aspiration channel is configured to provide a suctionforce at the opening of the inner cannula.

In some implementations, the flexible torque coil includes a pluralityof threads. Each of the plurality of threads can be wound in a directionopposite to a direction in which one or more adjacent threads of theplurality of threads is wound. In some implementations, the flexibletorque coil includes a plurality of layers. Each of the plurality oflayers can be wound in a direction opposite to a direction in which oneor more adjacent layers of the plurality of layers is wound. In someimplementations, each layer can include one or more threads. Additionaldetails regarding the flexible torque coil are described above in regardto the discussion of the flexible cable with respect to at least FIGS.22A-22H.

In some implementations, the flexible outer tubing has a length thatexceeds the length of the endoscope in which the endoscopic instrumentis insertable. In some implementations, the flexible outer tubing has alength that is at least 100 times larger than an outer diameter of theflexible outer tubing. In some implementations, the flexible portion isat least 40 times as long as the cutting assembly.

FIGS. 40A-40B show a perspective view of an endoscopic tool 4000 and aportion of a drive assembly 4050 configured to drive the endoscopictool. FIG. 40B shows a perspective view of the endoscopic tool and theportion of the drive assembly configured to drive the endoscopic toolshown in FIGS. 40A-40B. Referring now also to FIGS. 41, 42 and 43, FIG.41 shows a top view of the endoscopic tool 4000 and a top exposed viewof the portion of the drive assembly 4050 shown in FIGS. 40A-40B. FIG.42 shows a cross-sectional view of the endoscopic tool 4000 and theportion of the drive assembly 4050 across the section A-A. FIG. 43 showsan enlargedl view of the drive connector of the endoscope and theportion of the drive assembly 4050. FIG. 44 shows a perspective view ofthe endoscopic tool 4000 and a portion of the drive assembly shown inFIGS. 40A-40B. FIG. 45 shows a cross-sectional view of the endoscopictool and the portion of the drive assembly across the section B-B. FIG.46 shows an enlarged cross-sectional view of the rotational couplersection of the endoscopic tool. FIG. 47A and FIG. 47B show a top viewand a cross-sectional view of the rotational coupler of the endoscopictool.

The endoscopic tool 4000, as shown in FIGS. 40A-47B, may be configuredto be inserted within an instrument channel of an endoscope. Examples ofthe endoscope can include a gastroscope, such as a colonoscope, alaryngoscope, or any other flexible endoscope. The endoscopic tool caninclude a flexible portion 4002 that is shaped, sized and configured tobe inserted within the instrument channel, while a remaining portion ofthe endoscopic tool 4000 can be configured to remain outside theinstrument channel of the endoscope. The flexile portion 4002 can beshaped and sized to fit within the instrument channel and be configuredto navigate through a tortuous path defined by the instrument channelwhile the endoscope is inserted within the patient. In the case ofcolonoscopes, the endoscope can form a series of bends of over at least60 degrees and in some situations, over 90 degrees.

The endoscopic tool 4000 can include a cutting assembly 4010 configuredto resect material at a site within a subject. The cutting assembly 4010can be similar to the cutting assembly 160 described in FIG. 1C andelsewhere in the description and figures. In some implementations, thecutting assembly 4010 can include an outer cannula and an inner cannuladisposed within the outer cannula. The outer cannula can define anopening 4012 through which material to be resected can enter the cuttingassembly 4010. In some implementations, the opening 4012 is definesthrough a portion of the radial wall of the outer cannula. In someimplementations, the opening may extend around only a portion of theradius of the outer cannula, for example, up to one third of thecircumference of the radial wall. As the aspiration channel 4090 extendsbetween the aspiration port 4092 and the opening 4012, any suctionapplied at the aspiration port 4092 causes a suction force to be exertedat the opening 4012. The suction force causes material to be introducedinto the opening of the outer cannula, which can then be cut by theinner cannula of the cutting assembly.

The inner cannula can include a cutting section that is configured to bepositioned adjacent to the opening 4012 such that material to beresected that enters the cutting assembly via the opening 4012 can beresected by the cutting section of the inner cannula. The inner cannulamay be hollow and an inner wall of the inner cannula may define aportion of an aspiration channel that may extend through the length ofthe endoscopic tool. A distal end of the inner cannula can include thecutting section while a proximal end of the inner cannula can be opensuch that material entering the distal end of the inner cannula via thecutting section can pass through the proximal end of the inner cannula.In some implementations, the distal end of the inner cannula can comeinto contact with an inner surface of a distal end of the outer cannula.In some implementations, this can allow the inner cannula to rotaterelative to the outer cannula along a generally longitudinal axis,providing more stability to the inner cannula while the inner cannula isrotating. In some implementations, the size of the opening can dictatethe size of the materials being cut or resected by the inner cannula. Assuch, the size of the opening may be determined based in part on thesize of the aspiration channel defined by the inner circumference of theflexible torque coil.

The endoscopic instrument 4000 can include a flexible torque coil 4080that is configured to couple to the proximal end of the inner cannula ata distal end of the flexible torque coil 4080. The flexible torque coilcan include a fine coil with multiple threads and multiple layers, whichcan transmit the rotation of one end of the flexible torque coil to anopposite end of the flexible torque coil. Each of the layer of thread ofthe flexible torque coil can be wound in a direction opposite to adirection in which each of the layer of thread adjacent to the layer ofthread is wound. In some implementations, the flexible torque coil caninclude a first layer of thread wound in a clockwise direction, a secondlayer of thread wound in a counter-clockwise direction and a third layerof thread wound in a clockwise direction. In some implementations, thefirst layer of thread is separated from the third layer of thread by thesecond layer of thread. In some implementations, each of the layers ofthread can include one or more threads. In some implementations, thelayers of thread can be made from different materials or have differentcharacteristics, such as thickness, length, among others.

The flexibility of the torque coil 4080 allows the coil to maintainperformance even in sections of the torque coil 4080 that are bent.Examples of the flexible torque coil 4080 include torque coils made byASAHI INTECC USA, INC located in Santa Ana, Calif., USA. In someimplementations, the flexible torque coil 4080 can be surrounded by asheath or lining to avoid frictional contact between the outer surfaceof the flexible torque coil 4080 and other surfaces. In someimplementations, the flexible torque coil 4080 can be coated withPolytetrafluoroethylene (PFTE) to reduce frictional contact between theouter surface of the flexible torque coil 4080 and other surfaces. Theflexible torque coil 4080 can be sized, shaped or configured to have anouter diameter that is smaller than the diameter of the instrumentchannel of the endoscope in which the endoscopic tool is to be inserted.For example, in some implementations, the outer diameter of the flexibletorque coil can be within the range of 1-4 millimeters. The length ofthe flexible torque coil can be sized to exceed the length of theendoscope. In some implementations, the inner wall of the flexibletorque coil 4080 can be configured to define another portion of theaspiration channel that is fluidly coupled to the portion of theaspiration channel defined by the inner wall of the inner cannula of thecutting assembly 4010. A proximal end of the flexible torque coil 4080can be coupled to a proximal connector assembly 4070, details of whichare provided below.

The endoscopic instrument 4000 can include a flexible outer tubing 4086that can be coupled to the proximal end of the outer cannula. In someimplementations, a distal end of the flexible outer tubing 4086 can becoupled to the proximal end of the outer cannula using a couplingcomponent. In some implementations, the outer cannula can be configuredto rotate responsive to rotating the flexible outer tubing. In someimplementations, the flexible outer tubing 4086 can be a hollow, braidedtubing that has an outer diameter that is smaller than the instrumentchannel of the endoscope in which the endoscopic instrument 4000 is tobe inserted. In some implementations, the length of the flexible outertubing 4086 can be sized to exceed the length of the endoscope. Theflexible outer tubing 4086 can define a bore through which a portion ofthe flexible outer tubing 4086 extends. The flexible outer tubing 4086can include braids, threads, or other features that facilitate therotation of the flexible outer tubing 4086 relative to the flexibletorque coil, which is partially disposed within the flexible outertubing 4086.

The endoscopic instrument 4000 can include a rotational coupler 4030configured to be coupled to a proximal end of the flexible outer tubing4086. The rotational coupler 4030 may be configured to allow an operatorof the endoscopic tool to rotate the flexible outer tubing 4086 via arotational tab 4032 coupled to or being an integral part of therotational coupler 4030. By rotating the rotational tab 4032, theoperator can rotate the flexible outer tubing and the outer cannulaalong a longitudinal axis of the endoscope and relative to the endoscopeand the inner cannula of the cutting assembly 4010. In someimplementations, the operator may want to rotate the outer cannula whilethe endoscopic instrument is inserted within the endoscope while theendoscope is within the patient. The operator may desire to rotate theouter cannula to position the opening of the outer cannula to a positionwhere the portion of the radial wall of the outer cannula within whichthe opening is defined may aligned with the camera of the endoscope suchthat the operator can view the material entering the endoscopicinstrument for resection via the opening. This is possible in partbecause the opening is defined along a radial wall extending on a sideof the outer cannula as opposed to an opening formed on the axial wallof the outer cannula.

In some implementations, a proximal end 4034 of the rotational coupler4030 can be coupled to a lavage connector 4040. In some implementations,the rotational coupler 4030 can be a rotating luer component that allowsa distal end 4036 of the rotational coupler 4030 rotate relative to theproximal end 4034 of the rotational coupler 4030. In this way, when theflexible outer tubing 4086 is rotated, the component to which theproximal end of the rotational coupler 4030 is coupled, is not caused torotate. In some implementations, the proximal end 4034 of the rotationalcoupler 4030 can be coupled to an outer tubular member 4044 configuredto couple the proximal end 4034 of the rotational coupler 4030 to thelavage connector 4040. The rotational coupler 4030 can define a borealong a central portion of the rotational coupler 4030 through which aportion of the flexible torque coil 4080 extends. In someimplementations, the rotational coupler 4030 can be a male to malerotating luer connector. In some implementations, the rotational couplercan be configured to handle pressures up to 1200 psi.

The lavage connector 4040 can be configured to introduce irrigationfluid into the endoscopic tool 4000. The lavage connector 4040 includesa lavage port 4042 configured to engage with an irrigation source, suchas a water container. In some implementations, the lavage connector 4040can be a Y port used in fluid delivery systems that complies withmedical device industry standards and is sized to couple to the flexibleouter tubing 4086 or the outer tubular member 4044 that serves to couplea distal end 4048 of the lavage connector 4040 to the proximal end 4034of the rotational coupler 4030. In some implementations, the lavageconnector can define a hollow channel between the proximal end 4046 andthe distal end 4048 of the lavage connector 4040 that is sized to allowthe flexible torque coil 4080 to pass through the hollow channel definedthrough the lavage connector 4040.

As described above, the proximal connector assembly 4070 is configuredto be coupled to a proximal end of the flexible torque coil 4080. Theproximal connector assembly 4070 can be configured to engage with thedrive assembly 4050 that is configured to provide torque to the innercannula via the proximal connector assembly 4070 and the flexible torquecoil 4080. The proximal connector assembly 4070 can further define aportion of the aspiration channel and be configured to fluidly couplethe aspiration channel to a vacuum source to facilitate the removal ofmaterial entering the aspiration channel. In some implementations, aproximal end of the proximal connector assembly 4070 can include anaspiration port 4092 through which the material that enters theendoscopic tool 4000 can be withdrawn from the endoscopic tool 4000.

In some implementations, the endoscopic tool 4000 can be configured tobe driven by the drive assembly 4050. The drive assembly 4050 isconfigured to provide rotational energy from an energy source to theendoscopic tool 4000. The drive assembly 4050 can include a housing 4060that may house a first beveled gear 4054 and a second beveled gear 4056that are positioned such that the rotation of the first beveled gear4054 causes a rotation of the second beveled gear 4056. The secondbeveled gear 4056 can be coupled to a drive receptacle that is sized andshaped to receive and engage with the proximal connector assembly 4070of the endoscopic tool 4000. In some implementations, the first beveledgear 4054 can be coupled to a motor (not shown) or other rotationalsource via a rotational input shaft 4052.

The proximal connector assembly 4070 can include a hollow drive shaft4072, a coupler 4076 through which the hollow drive shaft 4072 passesand a tensioning spring 4074 coupled to the hollow drive shaft 4072. Adistal end of the drive shaft 4072 can be coupled to the proximal end ofthe flexible torque coil 4080. In some implementations, the drive shaft4072 and the flexible torque coil 4080 can be permanently coupled to oneanother. In some implementations, the drive shaft 4072 and flexibletorque coil 4080 can be coupled using a coupler, a press fit, a weld,such as a butt weld, or any other attachment means that allows theflexible torque coil 4080 to rotate when the drive shaft 4072 rotatesand to allow material passing through the flexible torque coil 4080 toflow through the drive shaft 4072. A proximal end of the drive shaft4072 can define the aspiration port 4092. In some implementations, theaspiration port 4092 can be configured to engage with a vacuum sourcecausing material entering the opening 4012 to flow through theaspiration channel 4090 and out of the endoscopic tool through theaspiration port 4092.

A coupler 4076, such as a hex-shaped coupler, can be configured tocouple with the hollow drive shaft. In some implementations, thehex-shaped coupler is a part of the hollow drive shaft. The coupler 4076can include an outer wall that is configured to engage with an innerwall of a drive receptacle 4058. The drive receptacle 4058 is coupled tothe second beveled gear 4056 and is configured to rotate when the secondbeveled gear 4056 rotates. In some implementations, the drive receptacle4058 can be a hollow cylindrical tube. In some implementations, aproximal end 4059 of the drive receptacle 4058 can include an openingdefined by an inner wall of the proximal end of the drive receptacle4058 that has a diameter that smaller than the inner diameter of theremaining portion of the drive receptacle 4058. In some implementations,the diameter of the opening through the proximal end 4059 of the drivereceptacle 4058 can be large enough to receive the drift shaft 4072 butsmall enough to prevent the tensioning spring 4074 coupled to the driveshaft 4072 from passing through the opening. In some implementations,the inner diameter of the remaining portion of the drive receptacle issized to engage with the coupler 4076.

The tensioning spring 4074 can be biased in such a way that, duringoperation of the endoscopic tool 4000, the tensioning spring 4074 mayprevent the drive shaft 4072, the flexible torque coil 4080 and theinner cannula from sliding towards the proximal end of the endoscopictool 4000. In some implementations, without the tensioning spring 4074,the inner cannula may slide away from the distal end of the endoscopictool 4000. This may be due to a force applied by the material to beresected at the opening 4012. In some implementations, the tensioningspring 4074 provides a countering force that prevents the inner cannulafrom sliding away from the distal end when the inner cannula comes intocontact with the material to be resected at the opening 4012. In someimplementations, the tensioning spring 4074 can be configured to biasthe distal end of the inner cannula to contact an inner wall of thedistal end of the outer cannula. In some implementations, the tensioningspring 4074 can be sized and biased such that the distal tip of theinner cannula can contact the inner distal wall of the outer cannula.This may limit any lateral or undesired movement generated due to whipat the distal end of the inner cannula caused by the rotation of theflexible torque coil.

The housing 4060 can be configured to engage with an aspiration end cap4062 and a locking collar 4064. In some implementations, the aspirationend cap 4062 can be configured to allow a vacuum source to maintain asecure connection with the aspiration port 4092 of the drive shaft 4072.In some implementations, the aspiration end cap 4062 can be configuredto allow the drive shaft 4072 to rotate while maintaining a secureconnection between the vacuum source and the aspiration port 4092 of thedrive shaft 4072. In some implementations, the aspiration end cap 4062can be configured to be secured to a portion of the housing 4060 in sucha way that the aspiration port of the drive shaft 4072 is accessible viaan opening of the aspiration end cap 4062. In some implementations, thevacuum source can be coupled to the end cap 4062 such that the vacuumsource does not rotate along with the proximal end of the drive shaft4072. In some implementations, one or more bearings or bushings can beused to allow facilitate a fluid connection between the aspiration port4092 of the drive shaft 4072 and the vacuum source without causing thevacuum source to rotate with the drive shaft 4072.

The locking collar 4064 can be configured to secure the lavage connector4040 to the proximal connector assembly 4070. In some implementations,the locking collar 4064 can be configured to secure a proximal end 4046of the lavage connector 4040 to the housing 4060 of the drive assembly4050. The locking collar 4064 can further be configured to prevent theproximal connector assembly 4070 from disengaging with the drivereceptacle 4058 and moving towards the distal end of the endoscopic tool4000. In some implementations, the locking collar 4064 can be configuredto secure a lining 4082 within which the flexible torque coil 4080 isdisposed to the flexible torque coil 4080, the drive shaft 4072 or thehousing 4060. In some implementations, the lining 4082 can serve as aheat shrink to reduce the dissipation of heat generated in the flexibletorque coil to other components of the endoscopic tool. In someimplementations, the outer wall of the lining 4082 can define a portionof the irrigation channel, while the inner wall of the lining 4082 canserve to prevent any material passing through the aspiration channelfrom escaping through the walls of the flexible torque coil. In someimplementations, the lining 4082 can also prevent the irrigation fluidpassing through the irrigation channel to flow into the aspirationchannel 4090 through the walls of the flexible torque coil 4080.

The distal end 4048 of the lavage connector 4040 can be configured toengage with an inner wall of the outer tubing 4044. In someimplementations, the distal end 4048 of the lavage connector 4040 can bepress fit into a proximal end of the outer tubing 4044. In someimplementations, a connector connecting the distal end 4048 of thelavage connector 4040 and the outer tubing can be used. The inner wallof the outer tubing 4044 and the outer wall of the lining 4082 candefine a portion of the irrigation channel 4096. The outer tubing 4044can extend from the distal end 4048 of the lavage connector 4040 to aproximal end 4034 of the rotational coupler 4030. The distal end of theouter tubing 4044 can be configured to engage with the proximal end 4034of the rotational coupler 4030.

In some implementations, the irrigation channel can extend from theirrigation entry port to the opening of the outer cannula. Theirrigation channel can be defined by the inner wall of the outer tubularmember, the rotational coupler, the inner wall of the outer tubing andthe inner wall of outer cannula. In some implementations, the irrigationchannel can also be defined by the outer wall of the inner cannula andthe outer wall of the flexible torque coil 4080. In someimplementations, the endoscopic instrument 4000 can also include thehollow lining 4082 that is sized to fit around the flexible torque coil4080. In some implementations, the hollow lining 4082 can serve as abarrier between the irrigation channel 4096 and the aspiration channel4090. In some implementations, the hollow lining 4082 can prevent air orother fluids to seep through the threads of the flexible torque coil4080. In addition, the hollow lining can allow the aspiration channel tomaintain a suction force throughout the length of the aspiration channelby preventing air to escape or enter through the threads of the flexibletorque coil 4080.

As described above, the cutting assembly 4010 includes the outercannula. The braided tubing 4086 is coupled to the outer cannula suchthat rotating the rotational tab 4032 of the rotational coupler 4030results in rotating the outer cannula. The outer cannula includes theopening 4012 at a distal end of the outer cannula. The opening isdefined within a portion of the radial wall of the outer cannula and mayonly extend around a portion of the radius of the outer cannula. As theaspiration channel 4090 extends between the aspiration port 4092 and theopening 4012, any suction applied at the aspiration port 4092 causes asuction force to be exerted at the opening 4012. The suction forcecauses material to be introduced into the opening of the outer cannula,which can then be cut by the inner cannula of the cutting assembly. Insome implementations, the aspirated material can be collected in acollection cartridge. In some implementations, the collection cartridgecan be fluidly coupled to the proximal end of the aspiration channel.

The inner cannula is disposed within the outer cannula and configured toresect any material that is sucked into or otherwise enters the opening4012 due to the suction force in the aspiration channel 4090. The innercannula can cut, resect, excise, debride or shave the material at theopening 4012 based in part on the interaction between the cuttingsurface and the wall of the outer cannula that defines the opening. Insome implementations, the rotational movement of the cutting surfacerelative to the opening 4012 can cause the material to be cut, resected,excised, or shaved. The flexible torque coil is coupled to the innercannula and causes the inner cannula to rotate along the longitudinalaxis of the inner cannula. As the outer cannula is coupled to the outertubing and is not rotationally coupled to the inner cannula or flexibletorque coil, the inner cannula rotates relative to the outer cannula. Agap between an outer wall of the inner cannula and the inner wall of theouter cannula defines a portion of the irrigation channel through whichirrigation fluid can flow from the lavage connector 4040 through theirrigation channel portion defined in part by the outer tubing 4044, therotational coupler 4030, and the flexible outer tubing 4086 towards thecutting surface of the inner cannula. The inner cannula may define aportion of the aspiration channel through which excised or resectedmaterial and the irrigation fluid can flow from the cutting surface ofthe inner cannula towards the aspiration port 4092.

The length of the cutting assembly 4010 may be sized to allow theendoscopic instrument 4000 to traverse through the length of theendoscope while the endoscope is inserted inside a patient. In someimplementations, the endoscope may be disposed within the patient andthe endoscope may include bends that exceed 60 degrees. As such, thelength of the cutting assembly 4010 may not exceed a few centimeters. Insome implementations, the length of the cutting assembly 4010 may beless than 1% of the length of the endoscopic tool 4000, or the length ofthe flexible portion of the endoscope within which the endoscopic toolcan be inserted. As described above, tissue sensing capabilities can beimplemented with the cutting assembly serving as a portion of the tissuesensor.

It should be appreciated that one or more seals, bearings, and othercomponents may be used. Seals may be used to maintain pressure, preventfluid leaks, or to securely engage components to one another. In someimplementations, bearings may be used to allow components to rotaterelative to one another without adversely affecting the components orthe performance of the endoscopic tool.

FIG. 45 shows a cross-sectional view of the endoscopic tool and theportion of the drive assembly across the section B-B. As shown in FIG.45, the second beveled gear 4056 may be configured to engage with thedrive receptacle 4058 of the drive assembly 4050. The proximal connector4070 of the endoscopic tool 4000, which includes the coupler 4076 andthe drive shaft 4072, can be inserted disposed within the drivereceptacle 4058. The outer wall of the coupler 4076 is sized to engagewith the inner wall of the drive receptacle 4058 such that when thedrive receptacle 4058 rotates, the coupler 4076 also rotates. Becausethe coupler 4076 is coupled to the drive shaft 4072, the drive shaft4072 may also rotate when the drive receptacle 4058 rotates. The innerwall of the drive shaft defines a portion of the aspiration channel4090.

FIG. 46 shows an enlarged cross-sectional view of the rotational couplersection of the endoscopic tool. FIG. 47A and FIG. 47B show a top viewand a cross-sectional view of the rotational coupler of the endoscopictool.

As shown in FIGS. 46-47B, the outer tubing 4044 is configured to engagewith the rotational coupler 4030. The outer tubing 4044 surrounds thelining 4082, which in turn surrounds the flexible torque coil 4080. Theinner wall of the flexible torque coil 4080 may define a portion of theaspiration channel 4090. The space between the inner wall of the outertubing 4044 and the outer wall or surface of the lining 4082 defines aportion of the irrigation channel. The tab 4032 can be configured to berotated by an operator of the endoscopic tool. In some implementations,the operator can rotate the tab 4032 while the endoscopic tool isinserted within the instrument channel of the endoscope and cause theouter cannula to rotate relative to the inner cannula and the endoscope.In this way, the operator can position the opening defined through theouter cannula by rotating the outer cannula to a desired position. Insome implementations, by providing a mechanism through which the outercannula can be rotated relative to the endoscope, an operator does nothave to be concerned about the position of the opening when theendoscopic tool is inserted within the instrument channel of theendoscope as the operator may be able to adjust the position of theopening by causing the outer cannula to rotate while the endoscopic toolis inserted within the endoscope.

FIG. 48 is a perspective view of a portion of the endoscopic toolinserted for operation within a drive assembly. The drive assembly 4800includes a drive interface 4810 configured to receive the proximalconnector 4070 of the endoscopic tool 4000. The proximal connector 4070can engage with the drive receptacle of the drive interface 4810 totranslate rotational energy generated by the drive assembly 4800 to thecutting assembly of the endoscopic tool 4000. The drive assembly 4800may include a pump 4820 or other fluid displacement device to controlthe flow of irrigation fluid into the lavage port 4042 of the endoscopictool 4000. In some implementations, the pump 4820 can be a peristalticpump. In some implementations, the pump can be any positive displacementfluid pump. In some implementations, a valve between the pump 4820 andthe lavage port 4042 can be placed to control an amount of irrigationfluid entering the endoscopic tool. In some implementations, the speedat which the pump 4820 operates can dictate the rate at which irrigationfluid enters the endoscopic tool. The drive assembly can also include apinch valve 4830. In some implementations, the pinch valve can beconfigured to control the application of a suction force applied to theaspiration channel.

In some implementations, an actuator, such as a control switch can beused to actuate the drive assembly 4800. In some implementations, theactuator can be a foot pedal, a hand switch, or any other actuationmeans for controlling the drive assembly 4800. In some implementations,the actuator can be coupled to the drive means, such as the pump 4820such that when the actuator is actuated, the pump 4820 begins to rotate,generating torque, which is translated to the proximal connector of theendoscopic tool via the drive interface 4810. The torque applied to theproximal connector can be translated via the flexible torque coil to theinner cannula, thereby causing the inner cannula to rotate relative tothe outer cannula. In some implementations, the actuator can be coupledto a pinch valve, such as the pinch valve 4830 to control the amount ofsuction applied to the aspiration channel. In some implementations, theactuator can be configured to actuate both the drive means and the pinchvalve simultaneously, such that the inner cannula is rotating whilesuction is applied through the aspiration channel. In someimplementations, the actuator can also be coupled to an irrigationcontrol switch or valve that controls the flow of irrigation fluid intothe endoscopic tool via the irrigation entry port 4042. In someimplementations, the actuator can be configured to actuate the drivemeans, the pinch valve for aspiration and the irrigation control switchfor irrigation simultaneously, such that the inner cannula is rotatingwhile suction is applied through the aspiration channel and irrigationfluid is supplied to the endoscopic tool.

In some implementations, a separate irrigation control switch can beconfigured to control the flow of irrigation fluid through theirrigation channel of the endoscopic tool. An operator can control thevolume of irrigation fluid provided to the irrigation channel via theirrigation control switch.

The drive assembly configuration shown in FIGS. 40A-48 is one exampleconfiguration of a drive assembly. It should be appreciated that theendoscopic tool 4000 can be configured to be driven by other driveassembly configurations. In some implementations, the proximal connectorportion of the endoscopic tool 4000 can be modified to engage with otherdrive assembly configurations. In some implementations, the endoscopictool 400 can be configured to be packaged as one or more differentcomponents that can be assembled prior to inserting the endoscopic toolwithin the instrument channel of the endoscope. In some implementations,the proximal connector of the endoscopic tool 4000 can be assembledtogether by an operator of the endoscopic tool after one or morecomponents of the endoscopic tool are caused to engage with componentsof the drive assembly.

FIG. 49 illustrates another implementation of the endoscopic tool and adrive assembly configured to drive the endoscopic tool. FIG. 50A is aside view of the endoscopic tool and drive assembly shown in FIG. 49.FIG. 50B is a cross-sectional view of the endoscopic tool and driveassembly shown in FIG. 49 taken along the section A-A. The endoscopictool 4910 is similar to the endoscopic tool 4000 but differs from theendoscopic tool 4000 in that the endoscopic tool 4910 has a differentproximal connector 4912. In this implementation, the proximal connector4912 can be coupled to a flexible torque coil, similar to the flexibletorque coil 4000 shown in FIGS. 40A-43, and include a proximal connectorengagement structure 4914 that is configured to engage with a driveassembly 4950. The proximal connector engagement structure can be sizedto engage with the drive assembly 4950 and include one or moreengagement surfaces configured to engage with the drive assembly 4950.The engagement surfaces can be coupled to the drive shaft includedwithin the proximal connector 4912 such that when the drive assembly4950 applies a rotating force to the engagement surfaces, the driveshaft rotates, which in turn causes the flexible torque coil and cuttingassembly of the endoscopic tool 4900 to rotate. In some implementations,the engagement surfaces 4914 can be cylindrical objects having an outerwall configured to engage with the drive assembly 4950 and an inner wallconfigured to engage with an outer wall of the drive shaft. In someimplementations, the proximal connector 4910 can also include a fin 4916or other structure that prevents the proximal connector 4910 andendoscopic tool 4910 from rotating relative to the drive assembly 4950.In some implementations, a side of the fin 4916 can rest on or engagewith a mounting structure 4936 a and 4936 b. In this way, when arotating force is applied by the drive assembly on the engagementsurfaces, the fin 4916 prevents the proximal connector 4910 fromrotating relative to the drive assembly 4950. The mounting structures4936 can be configured such that various components of the driveassembly 4950 can be mounted on or receive support from the mountingstructures 4936.

The drive assembly 4950 can include a retractable arm 4922, one or morespring loaded bearings 4924, a drive belt 4932 and a drive wheel 4936and one or more stationary bearings 4940. The retractable arm 4922 canbe configured to rotate between a first position and a second position.The spring loaded bearings 4924 can be mounted to the retractable arm4922 and positioned such that when the retractable arm 4922 is in thefirst position as shown in FIGS. 49 and 50A-B, the spring loadedbearings 4924 can apply a force on the proximal connector 4912 causingthe proximal connector to remain in place while the drive assembly 4950is actuated. The spring loaded bearings 4924 can be positioned such thatwhen the proximal connector 4912 of the endoscopic tool 4910 is engagedwith the drive assembly 4950, the spring loaded bearings 4924 engagewith an engagement component 4916 of a drive shaft (not shown) disposedwithin the proximal connector 4912. The engagement component 4916 can bestrategically located on the proximal connector 4912 such that when theretractable arm 4922 is in the first position, the spring loadedbearings 4924 come into contact with the engagement component 4916. Theengagement component 4916 can be cylindrical in shape and surround thedrive shaft disposed within the proximal connector 4912. The engagementcomponent 4916 can form a portion of the outer wall of the proximalconnector 4912. In some implementations, the engagement component 4916can rotate along a longitudinal axis of the proximal connector 4912 androtate relative to the proximal connector 4912. In some implementations,the drive wheel 4936 can be an elastomeric friction drive wheel.

A drive means, such as a motor or other driving source, can drive thedrive wheel 4936 mounted on a mounting shaft 4930 via the drive belt4934 that moves when the drive means is actuated. The drive belt 4934can cause the drive wheel 4936 to rotate. The engagement component 4916of the proximal connector 4912 can be configured to contact the drivewheel 4936 when the endoscopic tool is positioned within the driveassembly 4950. A stationary bearing 4940 of the drive assembly 4950 canbe positioned to hold the proximal connector 4912 in place while therotation of the drive wheel 4936 causes the engagement component 4916 torotate. The stationary bearing 4940 can also provide a force causing thedrive wheel 4936 and the engagement component 4916 to maintain contact.

As shown in FIG. 50B, when the retractable arm is in the first position,or engaged position, the spring loaded bearings 4924 are in contact withthe one or more engagement components 4916 at a first side and the drivewheel 4936 is in contact with the engagement components 4916 at a secondside. The spring loaded bearings may allow the engagement components4916 to rotate when the drive wheel is rotating. The fin 4914 restsagainst the mounting structures of the drive assembly preventing theendoscopic tool from rotating. When the retractable arm is in a secondposition, or disengaged position, the spring loaded bearings 4924 arenot in contact with the one or more engagement components 4916. As such,the endoscopic tool is not securely positioned within the driveassembly, and as such, actuating the drive means may not cause theflexible torque coil within the endoscopic tool to rotate.

It should be appreciated that the outer diameter of the endoscopicinstrument may be sized to be inserted within the instrument channel ofan endoscope while the endoscope is inserted within a patient. Inaddition, the endoscopic instrument may be sized to be large enough thatthe endoscopic tool comes into contact with the inner walls of theinstrument channel at various portions of the instrument channel tomaintain stability of the endoscopic instrument. If the outer diameterof the endoscopic instrument is much smaller than the inner diameter ofthe instrument channel, there may be a large amount of space between theendoscopic instrument and the inner wall of the instrument channel,which may allow the endoscopic instrument to move, vibrate or otherwiseexperience some instability during operation.

B. Improved Mechanisms for Controlling Outer Cannula for Use inEndoscopic Tool

It should be appreciated that one of the functions of the outer tubing4086 of the endoscopic tool shown in FIG. 40 is to allow an operator ofthe endoscopic tool to rotate the outer cannula such that the operatorcan position a cutting window defined through the outer cannula adjacentto a portion of tissue the operator desires to resect or otherwiseremove. The outer tubing, as described above, can be braided such thatrotational force applied at a proximal end of the outer tubing can bepropagated to the distal end of the outer tubing, which when coupled tothe outer cannula, causes rotation of the outer cannula. Due to thelength of the outer tubing and the flexibility of the outer tubing, therotational force applied at the proximal end may not propagate to thedistal end of the outer tubing, which gives rise to issues withproviding accurate and/or precise control of the position of the cuttingwindow of the outer cannula. Since the outer tubing 4086 also defines aportion of the irrigation path to supply irrigation fluid to thesurgical site, the irrigation fluid inside the outer tubing can alsointerfere with the outer tubing's ability to accurately rotate the outercannula responsive to a rotational force being applied at the proximalend.

In some implementations, the outer tubing can be a flexible torque coil(referred to as ‘outer flexible torque coil’) similar to the flexibletorque coil coupled to the inner cannula. The outer flexible torque coilcan be sized similar to the outer tubing 4086 and can have a diameterthat is greater than a diameter of the flexible torque coil coupled tothe inner cannula. The flexible torque coil can include a sealingcomponent, such as a lining, sleeve or other component that preventsirrigation fluid from seeping or leaking through the outer flexibletorque coil. In some implementations, the sealing component can beformed on an inner wall of the flexible torque coil. In someimplementations, the sealing component can be formed on an outer wall ofthe flexible torque coil.

In some implementations, a rotational system can be used to controlrotation of the outer cannula from a proximal end of the flexible outertubing (which remains outside of the subject's body during a procedure).The rotational system can be coupled to, mounted on or included withinthe flexible outer tubing. In some implementations, the rotationalsystem can include a bearing that is coupled to the outer cannula suchthat the outer cannula can rotate relative to the flexible outer tubingresponsive to an actuation of the rotational system.

In some implementations, the rotational system can include one or moreelectromagnets positioned proximate to the distal end of the flexibleouter tubing. The electromagnets can be positioned at predeterminedpositions around a radius of the flexible outer tubing and include wiresextending through the length of the flexible outer tubing. Theelectromagnets can be actuated via an electrical current, which uponapplication of the electrical current, can cause the electromagnet togenerate a magnetic field. A ferromagnetic component coupled to theouter cannula can be attracted to the electromagnet responsive to theelectrical current being applied, causing the outer cannula to rotate.In some implementations, the electromagnet can generate sufficientattractive forces to cause the outer cannula to remain locked in thatposition during cutting of tissue. In some implementations, a lockingmechanism can be actuated that causes the outer cannula to be locked inplace during actuation of the flexible torque coil and the inner cannulasuch that the outer cannula does not rotate during the procedure. Insome implementations, the outer tubing can include a series of magneticstrips with known polarities. The outer cannula, conversely, can becoupled to an electromagnet that depending on how it is actuated, cancause the outer cannula to rotate in a clockwise direction or a counterclockwise direction based on the magnetic polarities of the magneticstrips and the electromagnet.

In some implementations, the rotational system can include a pluralityof wires or threads that extend from the proximal end to the distal endof the flexible outer tubing. A first wire can be coupled to a gear orother linear-motion to rotational motion converter such that uponpulling the first wire, could cause the cannula coupled to the gear torotate in a first direction. Similarly, a second wire can be coupled toanother gear or other linear-motion to rotational motion converter suchthat upon pulling the second wire, the second wire could cause thecannula coupled to the gear to rotate in a second direction opposite thefirst direction. The amount of linear force applied to the first orsecond wire can determine an amount the outer cannula can rotate.

In some implementations, the rotational system can include a pluralityof gears or motors that are arranged sequentially and physically coupledto adjacent gears or motors and extending from the proximal end to thedistal end of the flexible outer tubing. The gears can be embedded inthe tubing or formed or otherwise adhered on a radial surface of theflexible outer tubing. The gear at the distal end of the flexible outertubing can be rotationally coupled to the outer cannula such that arotational force applied to a first gear at a proximal end can propagatethrough the plurality of gears sequentially and cause the outer cannulato rotate.

In some implementations, the rotational system can include an electroniccontrol module to control the amount of rotation of the outer cannula.The electronic control module can control an amount of current to theelectromagnets and control the timing of the current to provide granularcontrol of the outer cannula. In some implementations, the electroniccontrol module can control an amount of linear force applied to thethreads as described in some of the implementations above.

In some implementations, the rotational system can include a motorpositioned proximal to the outer cannula towards a distal end of theflexible outer tubing. One or more electrical wires carrying current tothe electrical motor can be included in or pass through or within theflexible outer tubing. The electrical motor can be rotationally coupledto the outer cannula and upon receiving an electrical current, can causethe outer cannula to rotate. The length of time for which the motor isactuated can control the amount of rotation of the outer cannula. Insome implementations, one or more gears can be used to limit the amountof rotation of the outer cannula from 0 to 360 degrees.

Surgical Instruments with Flexible Outer Tubing for Improved TorqueTransmission to End Effector

Referring further to FIG. 40 and now to FIGS. 51-52, in someimplementations, a surgical instrument, such as surgical instrument5100, can be configured to have improved torque transmission using aspecialized outer tubing. In various implementations, surgicalinstruments are used to traverse circuitous, tortuous pathways, such asthrough the intestine of a subject to reach a site within the subject atwhich an operation is to be performed by a distal end of the surgicalinstrument. Various components of the distal end, such as an innercannula and an outer cannula, are expected to be rotated using torquetransmitted to the distal end from an actuator coupled at a proximal endof the surgical instrument (the proximal end may be located outside ofthe subject). In existing systems, it has been found that there can benon-proportional relationship between the torque applied at the proximalend of the surgical instrument and the resulting rotation of thecomponents of the distal end.

For example, as discussed above, while a braided outer tubing may beused to propagate torque from the actuator to a distal end of the outertubing in order to rotate the outer cannula, the torque applied at theproximal end may not propagate in proportional manner to the distal endof the outer tubing, which gives rise to issues with providing accurateand/or precise control of the position of the cutting window of theouter cannula. In some implementations, the actuator may be a manualactuator to be rotated by a surgeon or other user performing a surgicalprocedure using the surgical instrument. To perform the surgicalprocedure effectively, the user may expect a smooth experience for usingthe actuator, such that rotating the actuator results in a consistent,proportional rotation response of the outer cannula. However, due to thelimitations of existing systems, it has been found that rotating theactuator may result in non-proportional behavior, including but notlimited to: a minimum threshold torque needing to be applied in order tocause any rotation of the outer cannula; a significant time delaybetween torque application and rotation response which is inconsistentwith an expected time delay that would be proportional to a length ofthe outer tubing; a rotation response of the outer cannula that is notproportional to the torque applied by the actuator (e.g., a ratio of (i)the torque applied by the actuator to the outer tubing to (ii) thetorque applied by the outer tubing to the outer cannula is not constantas a function of the torque applied by the actuator). These and variousother similar behaviors may result in “jerking” or other undesirablerotational movements, limiting the effectiveness of the surgicalprocedure being performed. It will be appreciated that while theseissues are discussed in the context of an surgical instrument, they maysimilarly arise in any surgical instrument that uses a flexible outertubing to transmit torque from a proximal end to a distal end in orderto rotate a component at the distal end. One possible cause of suchinconsistencies in the torque response may arise from the fact that theouter tubing can pass through a tortuous path and include several bends.Also, in some embodiments in which the outer tubing surrounds an innerflexible torque coil, interactions between the outer tubing and theinner flexible torque coil can interfere in the transmission of torquefrom the proximal end to the distal end.

In some implementations, the relationship between (i) the torque appliedby the actuator to the proximal end of the outer tubing (“τ_(proximal)”)to (ii) the torque applied by the outer tubing to the outer cannula canbe represented based on rates of rotation of the torque applied to theouter cannula by the distal end of the outer tubing (“τ_(distal)”). Forexample, a first rate of rotation associated with the τ_(proximal) canbe compared to a second rate of rotation of the outer cannula associatedwith the τ_(distal) (based on the τ_(proximal)), such as to determine apercentage difference between the first rate of rotation and the secondrate of rotation. The rates of rotation may be instantaneous rates oraverages rates during a predetermined period of time (e.g., for thefirst rate of rotation, a first predetermined period of time may beapproximately from when rotation of the actuator is initiated to whenrotation of the actuator is terminated; for the second rate of rotation,a second predetermined period of time may be approximately from whenrotation of the outer cannula in response to rotation of the actuator isinitiated to when rotation of the outer cannula is terminated). The rateof rotation may be represented as angle traversed per unit time (e.g.,degrees per second or radians per second). In some implementations, aratio of τ_(proximal) to τ_(distal) may be compared as a function ofτ_(proximal), which may indicate whether the rotation response of theouter tubing is linear (or nonlinear) as a function of τ_(proximal).These and other performance characteristics may be correspond to howaccurate and/or precise the outer tubing is in rotating a distalcomponent to a desired angular position. For example, with respect to anouter cannula defining a cutting window, it can be desirable to be ableto rotate the cutting window to a precise angular position in order toeffectively resect material.

Based on various such considerations, it has been identified that abraided outer tubing configured in accordance with the presentdisclosure (e.g., braided outer tubing 5140 as will be discussed withrespect to FIGS. 51-52) can have desirable performance for transmittingtorque from an actuator to an outer cannula or other distal component,such as a relatively low percentage difference between τ_(proximal) andτ_(distal), and/or a relatively linear rotation response as a functionof τ_(proximal).

Referring further to FIGS. 51-52, a surgical system 5100 including asurgical instrument 5110 is shown. The surgical instrument 5110 canincorporate features of various endoscopic instruments disclosed herein,such as endoscopic tool 4000. As shown in FIG. 51, the surgicalinstrument 5110 includes a cutting assembly 5120, a flexible outertubing 5140, and a flexible torque component 5160. The cutting assembly5120 is configured to resect material at a site within a subject. Thecutting assembly 5120 extends from a first proximal end 5122 to a firstdistal end 5124. The cutting assembly 5120 includes an outer cannula5126 and an inner cannula 5128 disposed within the outer cannula 5126.The outer cannula defines a cutting window 5130.

The flexible outer tubing 5140 extends from a proximal tubing end 5142to a distal tubing end 5144. The distal tubing end 5144 is coupled tothe outer cannula 5126. The flexible outer tubing 5140 is configured toreceive a torque (e.g., τ_(proximal)) at the proximal tubing end 5142and transmit the torque to the outer cannula (e.g., as τ_(distal)) torotate the outer cannula.

In some implementations, the surgical system 5100 includes a rotationalactuator 5180. The rotational actuator 5180 can be coupled to theproximal tubing end 5142 to rotate the flexible outer tubing 5140. Therotational actuator 5180 can include a manual control input 5182, whichcan be used to input the τ_(proximal) used to rotate the proximal tubingend 5142 (or to apply a control torque corresponding to a desiredτ_(proximal), such as if the rotational actuator 5180 includes gearsand/or a motorized actuator to drive the rotation of the proximal tubingend 5142).

The flexible outer tubing 5140 includes a plurality of first wires 5146,and a plurality of second wires 5148 oriented at an angle relative tothe plurality of first wires 5146. In some implementations, theplurality of second wires 5148 are oriented such that each second wire5148 in contact with an adjacent first wire 5146 is substantiallyperpendicular (e.g., 90 degrees plus or minus 15 degrees; plus or minus10 degrees; plus or minus 5 degrees) to the adjacent first wire 5146.

In some implementations, the number of the pluralities of wires 5146,5148 can be selected to improve the performance of the flexible outertubing 5140 in transmitting torque to the outer cannula 5126. However,there may also be countervailing behaviors that limit the ability tomodel the performance of the flexible outer tubing 5140 based only onthe number of wires (or to improve the performance of the flexible outertubing 5140 based only on increasing the number of wires). For example,as the number of wires increases, spacing between adjacent wires maydecrease, increasing the risk of frictional contact, which may reducethe efficiency of torque transmission to the distal tubing end 5144.

In some implementations, the number of first wires 5146 and the numberof second wires 5148 is greater than eight wires and less than or equalto twenty four wires. For example, the number of wires 5146, 5148 may besuch that a percentage difference between a rate of rotation of theproximal tubing end 5142 and the distal tubing end 5144 (and/or apercentage difference between an expected rate of rotation of the distaltubing end 5144 and an actual rate of rotation of the distal tubing end5144, where the expected rate of rotation is consistent with a smoothand/or proportional rotation response as discussed above) may be lessthan a threshold difference. In some implementations, the thresholddifference is less than or equal to thirty percent. In someimplementations, the threshold difference is less than or equal totwenty percent. In some implementations, the threshold difference isless than or equal to ten percent. In some implementations, thethreshold difference is less than or equal to five percent. In someimplementations, a measure of a ratio of τ_(proximal) to τ_(distal) as afunction of τ_(proximal) (e.g., over a predetermined range ofτ_(proximal) values) can be used to represent the performance of theflexible outer tubing 5140; for example, a ratio of the standarddeviation of the ratio to the average value of the ratio can be lessthan a threshold ratio (which can indicate how constant the ratio ofτ_(proximal) to τ_(distal) is as a function of τ_(proximal)). Thethreshold ratio can be less than or equal to 0.3. The threshold ratiocan be less than or equal to 0.2. The threshold ratio can be less thanor equal to 0.1. The threshold ratio can be less than or equal to 0.05.

In some implementations, the performance of the flexible outer tubing5140 may be optimized at a value within the range of greater than eighttotal wires and less than twenty four total wires. In an exampleimplementation, the performance of the flexible outer tubing 5140 hasbeen determined to be optimized with twelve first wires 5146 and twelvesecond wires 5148. It will be appreciated that the desires or optimalnumber of first wires 5146 and second wires 5148 can depend on materialproperties of the wires 5146, 5148, spacing between wires 5146, 5148,and other properties of the surgical system 5100. The wires 5146, 5148may be made from stainless steel (e.g., type 304V hard temperedstainless steel).

It should be noted that in a simulation of the performance of theflexible outer tubing 5140, simulated performance values for theflexible outer tubing 5140 were inconsistent with experimental values,and did not identify the optimized performance of the flexible outertubing 5140 having twelve first wires 5146 and twelve second wires 5148.As such, it may be difficult or impossible to determine the number ofwires 5146, 5148 having desired performance based on known principlesand, notably, the implementations described herein using greater thaneight total wires and less than twenty four total wires, andparticularly twelve first wires 5146 and twelve second wires 5148,provided unexpected performance advantages over other implementations.

Referring further to FIG. 52, a cross-section view of the flexible outertubing 5140 is shown. In some implementations, the flexible outer tubing5140 includes a base layer 5150 adjacent to the plurality of secondwires 5148 and a top layer 5154 adjacent to the plurality of first wires5146. The base layer 5150 and top layer 5154 may each include at leastone of an elastomer or a friction reducing additive. In someimplementations, the elastomer includes a thermoplastic elastomer suchas polyether block amide (e.g., PEBAX). In some implementations, thefriction reducing additive includes MOBILIZE, manufactured byCompounding Solutions, LLC of Lewinston, Me. The at least one of theelastomer or the friction reducing additive can reduce the likelihood ofthe wires 5146, 5148 sticking to each other, becoming kinked, orotherwise undergoing frictional losses during use that would reduce theefficiency of the flexible outer tubing 5140 in transmitting torque fromthe proximal tubing end 5142 to the distal tubing end 5144. In addition,the at least one of the elastomer or the friction reducing additive canreduce friction generated between the outer tubing 5140 and the innerflexible torque component 5160 when the outer tubing 5140 and the innerflexible torque component 5160 come in contact with one another, forinstance, when the surgical instrument 5100 has been passed through atortuous pathway. In some embodiments in which the surgical instrumentis insertable within a working channel of an endoscope, the at least oneof the elastomer or the friction reducing additive can reduce frictiongenerated between the outer tubing 5140 and the inner wall of theworking channel of the endoscope.

The flexible outer tubing 5140 defines an inner diameter 5156 and anouter diameter 5158. A ratio of the inner diameter 5156 to the outerdiameter 5158 may be greater than or equal to 0.5 and less than or equalto 0.95. The outer diameter 5148 may be less than 0.5 inches. The outerdiameter 5148 may be less than 0.25 inches. The outer diameter 5148 maybe greater than or equal to 0.05 inches and less than or equal to 0.5inches. The outer diameter 5148 may be greater than or equal to 0.11inches and less than or equal to 0.13 inches.

Referring back to FIG. 51, in some implementations, the cutting window5130 includes a material entry port 5184 through which material to beresected enters the cutting window 5130. The surgical instrument 5110can include an aspiration channel 5186 extending from the material entryport 5184 to a material exit port 5188. The material exit port 5186 isconfigured to be coupled to a vacuum source 5190, such that the resectedmaterial is received in the aspiration channel 5186 via the materialentry port 5184 and removed from the aspiration channel 5186 at thematerial exit port 5188.

In some implementations, the surgical instrument 5110 includes anirrigation channel 5192. The irrigation channel 5192 extends between theflexible outer tubing 5140 and the flexible torque component 5160, andfrom a proximal irrigation end 5194 to a distal irrigation end 5196. Theirrigation channel 5192 is configured to receive fluid at the proximalirrigation end 5194 from an irrigation source 5198, and output the fluidat the distal irrigation end 5196. As noted above, it will beappreciated that the irrigation fluid inside the flexible outer tubing5140 can also interfere with the ability of the outer tubing 5140 toaccurately rotate the outer cannula 5126 responsive to τ_(proximal)applied at the proximal tubing end 5142.

The flexible torque component 5160 is coupled to a third proximal end5200 of the inner cannula 5128, so that the flexible torque component5160 can rotate the inner cannula 5128 relative to the outer cannula5126. In some implementations, the flexible torque component 5160 isconfigured to be rotated by a flexible torque drive assembly 5202, whichis separate from the rotational actuator 5180.

It should be appreciated that aspects of the disclosure are not limitedto an endoscopic tool but rather, extend to other technological areaswhere there may be a desire to cause rotation of a component at aposition where providing a motor or rotational force generator proximateto the component may not be possible or practical. In various surgicalinstruments similar to surgical instrument 5110, a flexible outer tubingsimilar or identical to flexible outer tubing 5140 can be used toeffectively transmit torque to an end effector. The end effector may bea component which, like outer cannula 5126, is to be driven or rotatedas part of a surgical procedure. The end effector may include, withoutlimitation, components such as blades, pincers, scrapers, vacuums,grippers, or electromagnets. In some implementations, a surgicalinstrument includes an end effector and a flexible outer tubing. The endeffector is configured to be rotated by the flexible outer tubing toperform a surgical procedure at a site on or within a subject. Theflexible outer tubing extends from a proximal tubing end to a distaltubing end. The distal tubing end is coupled to the end effector so thatthe flexible outer tubing can receive a torque at the proximal tubingend and transmit the torque to the end effector. The flexible outertubing includes a plurality of first wires and a plurality of secondwires oriented at an angle relative to the plurality of first wires. Theplurality of first wires and plurality of second wires each include morethan eight wires and less than twenty four wires. The surgicalinstrument can incorporate (or be part of a system incorporating)various other components described herein, including but not limited toactuators and drive assemblies used to manipulate the surgicalinstrument, irrigation channels used to deliver fluid via the surgicalinstrument, and aspiration channels used to remove material from asubject.

It should be appreciated that the Figures shown herein are intended tobe for illustrative purposes only and are not intended to limit thescope of the application in any way. In addition, it should beappreciated that the dimensions provided herein are only exampledimensions and can vary based on specific requirements. For example, thedimensions may change to alter the aspiration rate, irrigation flow,amount of torque being provided, cutting speed, cutting efficiency,amongst others. Moreover, it should be appreciated that details withinthe drawings are part of the disclosure. Moreover, it should beappreciated that the shape, materials, sizes, configurations and otherdetails are merely illustrated for the sake of examples and personshaving ordinary skill in the art should appreciate that design choicescan alter any of the shape, materials, sizes and configurationsdisclosed herein. For the purpose of this disclosure, the term “coupled”means the joining of two members directly or indirectly to one another.Such joining may be stationary or moveable in nature. Such joining maybe achieved with the two members or the two members and any additionalintermediate members being integrally formed as a single unitary bodywith one another or with the two members or the two members and anyadditional intermediate members being attached to one another. Suchjoining may be permanent in nature or may be removable or releasable innature.

What is claimed is:
 1. A cutting tool, comprising: a cutting assemblyconfigured to resect material at a site within a subject, the cuttingassembly comprising an inner cannula disposed within an outer cannula,the outer cannula defining a cutting window; a flexible outer tubingconfigured to rotate the outer cannula, the flexible outer tubingincluding a plurality of first wires and a plurality of second wiresoriented at an angle relative to the plurality of first wires, theplurality of first wires and the plurality of second wires eachincluding more than eight wires and less than twenty four wires; and aflexible component configured to rotate the inner cannula relative tothe outer cannula.
 2. The cutting tool of claim 1, wherein the flexibleouter tubing is further configured to rotate the outer cannula with afirst rate of rotation, the first rate of rotation having a differenceof less than or equal to thirty percent compared to a second rate ofrotation of the cutting window, the difference based on a first numberof the plurality of first wires and a second number of the plurality ofsecond wires.
 3. The cutting tool of claim 2, wherein the difference isless than or equal to ten percent.
 4. The cutting tool of claim 2,wherein the first number and the second number is twelve.
 5. The cuttingtool of claim 2, wherein a spacing between at least two adjacent firstwires of the plurality of first wires decreases as a sum of the firstnumber and the second number increases.
 6. The cutting tool of claim 1,wherein the angle is ninety degrees.
 7. The cutting tool of claim 1,wherein the flexible outer tubing includes a base layer adjacent to theplurality of second wires, the base layer comprising an elastomer and afriction reducing additive, and a top layer adjacent to the plurality offirst wires, the top layer comprising the elastomer and the frictionreducing additive.
 8. The cutting tool of claim 1, wherein the cuttingwindow includes a material entry port through which material to beresected enters the cutting assembly, the cutting tool furthercomprising an aspiration channel that extends from the material entryport to a material exit port coupled to a vacuum source, the aspirationchannel configured to receive the resected material via the materialentry port and configured to remove the resected material from theaspiration channel at the material exit port.
 9. The cutting tool ofclaim 1, further comprising an irrigation channel that extends betweenthe flexible outer tubing and the flexible component, the irrigationchannel configured to receive fluid at a proximal irrigation end andoutput the fluid adjacent to the outer cannula.
 10. The cutting tool ofclaim 1, wherein the plurality of first wires and the plurality ofsecond wires comprise stainless steel.
 11. The cutting tool of claim 1,further comprising a manual rotational actuator configured to rotate theflexible outer tubing.
 12. The cutting tool of claim 11, furthercomprising a drive assembly separate from the manual rotational actuatorconfigured to rotate the flexible outer tubing.
 13. The cutting tool ofclaim 1, wherein the flexible outer tubing includes an outer diameterless than 0.5 inches.
 14. The cutting tool of claim 1, wherein theflexible outer tubing includes an inner diameter of the flexible outertubing having a ratio to an outer diameter of the flexible outer tubinggreater than or equal to 0.5 and less than or equal to 0.95.
 15. Acutting tool, comprising: a cutting assembly configured to resectmaterial at a site within a subject, the cutting assembly comprising aninner cannula disposed within an outer cannula, the outer cannuladefining a cutting window; a flexible outer tubing configured to rotatethe outer cannula relative to the inner cannula, the flexible outertubing including a plurality of first wires and a plurality of secondwires oriented at an angle relative to the plurality of first wires, theplurality of first wires and the plurality of second wires eachincluding twelve wires; and a flexible component configured to rotatethe inner cannula relative to the outer cannula.
 16. The cutting tool ofclaim 15, wherein the flexible outer tubing is further configured torotate the outer cannula with a first rate of rotation, the first rateof rotation having a difference of less than ten percent compared to asecond rate of rotation of the cutting window.
 17. The cutting tool ofclaim 15, wherein the flexible outer tubing includes a base layeradjacent to the plurality of second wires, the base layer comprising anelastomer and a friction reducing additive, and a top layer adjacent tothe plurality of first wires, the top layer comprising the elastomer andthe friction reducing additive.
 18. The cutting tool of claim 15,further comprising an irrigation channel that extends between theflexible outer tubing and the flexible component, the irrigation channelconfigured to receive fluid at a proximal irrigation end and output thefluid adjacent to the outer cannula.
 19. The cutting tool of claim 15,further comprising a manual rotatable actuator rotating the flexibleouter tubing.
 20. The cutting tool of claim 15, wherein the flexibleouter tubing includes an inner diameter of the flexible outer tubinghaving a ratio to an outer diameter of the flexible outer tubing greaterthan or equal to 0.5 and less than or equal to 0.95.